Peritoneal Dialysis Systems, Devices, and Methods

ABSTRACT

An automated peritoneal dialysis system provides both cycler-assisted peritoneal dialysis treatment and also continuous ambulatory peritoneal dialysis (CAPD). The system includes a fluid preparation and treatment device with a concentrate dilution components connected to a source of purified water and medicament concentrate. The treatment device has at least one mixing container connected via a pump and valves to the sources, the valves and the pump mixing and diluting the concentrate to form a medicament. An auxiliary port is provided for attaching a CAPD container and for receiving medicament. A controller is programmed to control the fluid preparation and treatment device to implement one or more cycler-assisted peritoneal dialysis treatment cycles using medicament from the mixing container and also to control the preparation of additional dialysate at the end of the cycler-assisted peritoneal dialysis treatment cycles to dispense additional dialysate through the auxiliary port for use in CAPD.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/348,533 filed Mar. 28, 2014, which is the national stage entry ofInternational Application No. PCT/US2012/056781 filed on Sep. 23, 2012,which claims the benefit of International Application PCT/US2012/030350filed Mar. 23, 2012. The entirety of each of these applications isexpressly incorporated by reference.

BACKGROUND

The disclosed subject matter relates generally to the treatment of endstage renal failure and more specifically to devices, methods, systems,improvements, and components for performing peritoneal dialysis.

Peritoneal dialysis is a mature technology that has been in use for manyyears. It is one of two common forms of dialysis, the other beinghemodialysis, which uses an artificial membrane to directly cleanse theblood of a renal patient. Peritoneal dialysis employs the naturalmembrane of the peritoneum to permit the removal of excess water andtoxins from the blood.

In peritoneal dialysis, sterile peritoneal solution is infused into apatient's peritoneal cavity using a catheter that has been insertedthrough the abdominal wall. The solution remains in the peritonealcavity for a dwell period. Osmosis exchange with the patient's bloodoccurs across the peritoneal membrane, removing urea and other toxinsand excess water from the blood. Ions that need to be regulated are alsoexchanged across the membrane. The removal of excess water results in ahigher volume of fluid being removed from the patient than is infused.The net excess is called ultrafiltrate, and the process of removal iscalled ultrafiltration. After the dwell time, the dialysate is removedfrom the body cavity through the catheter.

Peritoneal dialysis requires the maintenance of strict sterility becauseof the high risk of peritoneal infection. The risk of infection isparticularly high due to the long periods of time that the patient isexposed to the dialysate.

In one form of peritoneal dialysis, which is sometimes referred to ascycler-assisted peritoneal dialysis, an automated cycler is used toinfuse and drain dialysate. This form of treatment can be doneautomatically at night while the patient sleeps. One of the safetymechanisms for such a treatment is the monitoring by the cycler of thequantity of ultrafiltrate. The cycler performs this monitoring functionby measuring the amount of fluid infused and the amount removed tocompute the net fluid removal.

The treatment sequence usually begins with an initial drain cycle toempty the peritoneal cavity of spent dialysate, except on so-called “drydays” when the patient begins automated treatment without a peritoneumfilled with dialysate. The cycler then performs a series of fill, dwell,and drain cycles, typically finishing with a fill cycle.

The fill cycle presents a risk of over-pressurizing the peritonealcavity, which has a low tolerance for excess pressure. In traditionalperitoneal dialysis, a dialysate container is elevated to certain levelabove the patient's abdomen so that the fill pressure is determined bythe height difference. Automated systems sometimes employ pumps thatcannot generate a pressure beyond a certain level, but this system isnot foolproof since a fluid column height can arise due to apatient-cycler level difference and cause an overpressure. A reverseheight difference can also introduce an error in the fluid balancecalculation because of incomplete draining.

Modern cyclers may fill by regulating fill volume during each cycle. Thevolume may be entered into a controller based on a prescription. Theprescription, which also determines the composition of the dialysate,may be based upon the patient's size, weight, and other criteria. Due toerrors, prescriptions may be incorrect or imperfectly implementedresulting in a detriment to patient well-being and health.

Systems that measure pressure have been proposed. For example, apressure sensor in contact with a fluid circuit at the cycler has beendescribed. The sensor indicates the pressure at the proximal end of thefill/drain line. During operation, a controller connected to thepressure sensor changes the operation of the peritoneal dialysis machinein response to changes in pressure sensed by the pressure sensor.

SUMMARY

Briefly, an automated peritoneal dialysis system provides variousfeatures including prescription-driven dialysis fluid preparation, anintegrated disposable fluid circuit, and sensor capabilities that allowaccurate filling and draining control with high safety margins. Featuresinclude a peritoneal fluid circuit with a pressure sensor at either endand methods and devices for using the pressure signals. Other featuresand embodiments are disclosed.

Objects and advantages of embodiments of the disclosed subject matterwill become apparent from the following description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will hereinafter be described in detail below with referenceto the accompanying drawings, wherein like reference numerals representlike elements. The accompanying drawings have not necessarily been drawnto scale. Where applicable, some features may not be illustrated toassist in the description of underlying features.

FIG. 1 shows a peritoneal dialysis system with pressure sensors locatedat a patient and at a peritoneal dialysis cycler, according toembodiments of the disclosed subject matter.

FIG. 2A shows a pod-type pressure sensor, according to embodiments ofthe disclosed subject matter.

FIG. 2B shows a peritoneal dialysis tubing set with an integratedpressure sensor according to embodiments of the disclosed subjectmatter.

FIG. 3A shows a cycler and peritoneal dialysis fill/drain line,according to embodiments of the disclosed subject matter.

FIG. 3B shows a fill/drain line with a peritoneal catheter according toembodiments of the disclosed subject matter.

FIG. 3C shows a coextruded air line and fluid line which may be employedin an embodiment of a peritoneal fill/drain line set having a peritonealfill/drain line and pressure pod type pressure sensor thereon.

FIGS. 4A and 4B show a fill/drain line with a peritoneal catheteraccording to further embodiments of the disclosed subject matter.

FIGS. 5A-5C show threads of a procedure for monitoring fill/drainprocesses of a cycler using pressure sensors according to embodiments ofthe disclosed subject matter.

FIG. 6A shows a peritoneal dialysis solution preparation and treatmentsystem according to embodiments of the disclosed subject matter.

FIG. 6B shows the peritoneal dialysis solution preparation and treatmentsystem of FIG. 6A in a first phase of fluid preparation in which osmoticagent is added to a batch container, according to embodiments of thedisclosed subject matter.

FIG. 6C shows the peritoneal dialysis solution preparation and treatmentsystem of FIG. 6A in a second phase of fluid preparation in which adialysate precursor is obtained by dilution and mixing the contents ofthe batch container, according to embodiments of the disclosed subjectmatter.

FIG. 6D shows the peritoneal dialysis solution preparation and treatmentsystem of FIG. 6A in a third phase of fluid preparation in which thedialysate precursor properties are verified, according to embodiments ofthe disclosed subject matter.

FIG. 6E shows the peritoneal dialysis solution preparation and treatmentsystem of FIG. 6A in a fourth phase of fluid preparation in whichdialysate precursor is further prepared by addition of electrolyte tothe batch container, according to embodiments of the disclosed subjectmatter.

FIG. 6F shows the peritoneal dialysis solution preparation and treatmentsystem of FIG. 6A in a fifth phase of fluid preparation in which end-usedialysis solution is prepared by adjustment of the dilution of the batchcontainer contents, according to embodiments of the disclosed subjectmatter.

FIG. 6G shows the peritoneal dialysis solution preparation and treatmentsystem of FIG. 6A in a sixth phase of fluid preparation in whichdialysis solution in the batch container is verified, according toembodiments of the disclosed subject matter.

FIG. 6H and FIG. 6K show the peritoneal dialysis solution preparationand treatment system of FIG. 6A in in various treatment modes, accordingto embodiments of the disclosed subject matter.

FIG. 7A shows a disposable for use with the peritoneal dialysis systemof FIG. 6A according to embodiments of the disclosed subject matter.

FIGS. 7B and 7C shows an embodiment of the disposable of FIG. 7A in useon a cycler and fluid preparation device according to embodiments of thedisclosed subject matter.

FIG. 7D illustrates a configuration that employs bagged water as asource of water for dilution rather than a water purification plant.

FIG. 8A shows a schematic diagram of a peritoneal dialysis system thatgenerates peritoneal dialysis solution from concentrate according toembodiments of the disclosed subject matter.

FIGS. 8B and 8C show how the valves of a manifold module operate toselectively block and permit the flow of fluid through the manifoldmodule.

FIGS. 8D and 8E show fluid circuit embodiments.

FIG. 9 shows a schematic diagram of a water purifier and with featuresto support renal replacement therapy delivery systems according toembodiments of the disclosed subject matter.

FIG. 10 shows a schematic diagram of a peritoneal dialysis system thatuses pre-mixed dialysate according to embodiments of the disclosedsubject matter.

FIG. 11 shows a flow chart describing respective methods for preparing aperitoneal dialysis system for treatment and performing a treatmentusing either pre-mixed dialysate or concentrate.

FIG. 12 shows a method for fluid circuit priming which may be used inone of the processes shown in FIG. 11 according to embodiments of thedisclosed subject matter.

FIG. 13 shows a method for fluid preparation which may be used in one ofthe processes shown in FIG. 11 according to embodiments of the disclosedsubject matter.

FIG. 14 shows a method of pressure testing a sterile filter which may beused in one of the processes shown in FIG. 11 according to embodimentsof the disclosed subject.

FIG. 15 shows a method for priming a patient line leading to a patientaccess, which may be used in one of the processes shown in FIG. 11according to embodiments of the disclosed subject.

FIG. 16 shows a method for disconnecting and flushing a used fluidcircuit which may be used in one of the processes shown in FIG. 11according to embodiments of the disclosed subject.

FIGS. 17A-17H, 17J-17N, and 17P-17T illustrate steps of preparation for,and termination of, a treatment which may be used in one of theprocesses shown in FIG. 11 according to embodiments of the disclosedsubject.

FIG. 18 illustrates a control system according to embodiments of thedisclosed subject matter.

FIG. 19 shows a fluid path and actuator layout according to embodimentsof the disclosed subject matter.

FIG. 20 shows a sequential solution mixing system that employsconsistent volumetric displacement to provide predicted component ratiosof constituent fluids.

FIG. 21 shows a method for preparing and mixing a solution, such as amedicament, which may be used with any suitable system including thesystem of FIG. 20 and the foregoing PD dialysate mixing systemsdescribed elsewhere in the present specification.

FIG. 22A shows a system for mixing component fluids to form a batch andwhich includes a description of features for calibrating one or morepumps.

FIG. 22B is a flow chart for discussing a technique for mitigatingnon-linear effects during fluid preparation.

FIGS. 23A through 23C illustrate a self-sterilizing PD cycler/fluidpreparation system which employs flow switching and pumping in apermanent system.

DETAILED DESCRIPTION

Referring to FIG. 1, a peritoneal dialysis system 100 includes aperitoneal dialysis (PD) cycler 101 with an internal pump (not shown).The PD cycler 101 pumps dialysis solution from a container 106, such asa bag, or other source, to a patient access 114 through a fill/drainline 112 to a peritoneal catheter 114 into the peritoneum of a patient108. This happens during a fill cycle.

During a drain cycle, spent dialysate is withdrawn from the patient byflowing in reverse through the fill/drain line back to the cycler 101and out through a drain 104. The cycler 101 quantifies the volume offluid that is infused and drained and provides an accounting of thedifference to allow the net amount of fluid withdrawn from the patientto be determined.

The pump may be any suitable pump such as a diaphragm pump or aperistaltic pump. Alternatively, the cycler may rely on other fluidconveyance systems such as an over or under-pressurized supply/sumpcontainer, gravity feed or any other suitable mechanism.

A controller 116 allows the system to regulate a flow rate to ensure thepatient's peritoneal cavity is not over-pressurized. The flow regulationmay be accomplished by changing a speed of a pump or by means of avariable flow restrictor or any suitable mechanism conforming to therequirements of the type of fluid conveyance system employed.

Prior art systems have prevented exceeding a safe limit on peritonealpressure by a variety of mechanisms, including measuring pressure in thefill line using a pressure sensor located on the PD cycler and applyingfeedback control of the pump to ensure a limit is not exceeded. Anotherprior art device for preventing over-pressurization of the peritonealcavity limits the total head pressure by employing a gravitational feed.

An alternative may employ a pressure detection device 110 located at theend of a fill line 112, adjacent the patient 108, or at the access 114itself, to take pressure readings close to the patient. By usingpressure measurements from this location, the error in pressuremeasurement of the peritoneal cavity due to pressure loss in the fillline during filling of the cavity is eliminated. In this way the flowrate can be controlled by a continuous feedback loop to maintain thecavity pressure below a desired safety threshold. Locating the pressuresensor close to the patient also eliminates another source of errorwhich may arise from a level difference between the supply side of thefill line 112 and the catheter end of the fill line. That is, if thecycler 101 is located higher than the patient access, the gravitationalhead pressure of the fill line could cause a greater pressure thanindicated by a prior art pressure sensor located at the PD cycler whichmay not otherwise be accounted for, causing excessive pressure to beapplied. A low cycler may cause inadequate pressure and slow fillcycles.

In the embodiment of FIG. 1, to provide accurate pressure indication,the pressure detection device 110 is located close to the patient 108 tomaximize responsiveness to changes in the peritoneal cavity pressure andminimize the effect of pressure drop due to flow resistance. Anelectrical pressure transducer may be located at the end of the line.Alternatively, a pressure pod as described in the attached US patentpublication 20070179422 may be used. In an embodiment, a pressuretransducer may be located at the controller or cycler as shown in FIG. 1and also at the patient access to measure the pressure of the peritonealspace without the signal bias produced by line pressure drop in the line112.

FIG. 2A shows a pressure measurement pod 10. In the pod 10, air chamber45 is in communication with an air port 12 and air line 40 that can beconnected to a pressure transducer (not shown). Fluid flows through afluid chamber 60 between an inlet line 35 connected to an inlet port 70and out of the fluid chamber 60 through an outlet port 72 into an outletline 15. The pressure of the fluid in the fluid chamber 60 displaces adiaphragm 25 until the air chamber 45 and fluid chamber 60 are atequilibrium, which is preferably the situation when the air and fluidchambers 45 and 60 are at equal pressure.

The pod 10 is primarily made of two parts, a fluid-side shell 30 and anair-side shell 17, that, together, form an enclosure 5 that defines thefluid and air chambers 60 and 45. The ratio of the minimum to themaximum volume of the air chamber 45, including the volume of the line40 and port 12, is proportional to the total pressure variation that canbe measured by the transducer attached to the line 40.

Referring now to FIG. 3A, a fill/drain tubing set 309 has a pod 304 forindicating pressure. The pod 304 may conform to the design of pod 10 ofFIG. 2A and may be used to provide a pressure indication at a distal endof a fill/drain line 306. FIG. 3A shows a PD cycler 318 with source ofdialysate 320 and connectors 316 and 314 for the fill/drain line and apressure sensing line 302, respectively. The pressure sensing line 302connects a pressure transducer (not shown separately) on the PD cycler318 to the pod 304 to permit the transducer to read the pressure exertedon the diaphragm (not shown in FIG. 3A) of the pod 304. The pod 304 isconnected directly to the fill/drain line 306 in an inline configurationand close to an access connector 326 to which a peritoneal catheter 322can be connected by connector 324. The pressure sensing line 302 isattached to the fill/drain line 306, for example by a series ofconnectors 308, so that it runs parallel along the fill/drain line 306.The PD cycler 318 may also be provided with an additional pressuresensing device forming part of a fluid circuit to which the fill/drainline 306 is attached and configured to measure the pressure in thefill/drain line 306 close to the PD cycler 318.

Thus, in the present embodiments, the pressures at each end of thefill/drain line 306 may be determined by a controller that operates thecycler at all times during operation of the PD cycler 318 and applied ascontinuous input signals to the controller during fill and drainoperations. As discussed below, these inputs can be used to allow thecapture and storage of vital signs, detection of flow restrictions andkinks in the fill/drain line 306, and allow the regulation of flow ratewhile managing the pressure within the peritoneum.

FIG. 2B shows a peritoneal dialysis tubing set 60 with an integratedpressure sensor 45 located at a distal end of a fill-drain line 47. Thefill-drain line may have one or two lumens for shared or separate filland drain use, respectively. A pressure transducer 45 is in pressurecommunication with a lumen of the fill-drain line 47. If there areseparate fill and drain lumens, each may carry its own pressuretransducer 45 or only one, for example, the fill line, may carry apressure transducer 45. The transducer may be, for example, a straingauge component that reacts to isotropic pressure (e.g. fully wetted andimmersed) or it may be a strain gauge component built into the wall ofan inline fluid conveying component. Other configurations are alsopossible to achieve the effect of providing pressure sensing at thedistal end of the fill-drain line 47. A pair (or more, as necessary) ofconductors 48 run along the length of the fill-drain line 47 to connectto an electrical connector 50 which connects to a driver circuit 51. Thedriver circuit may contain a power supply and reader circuit or othersuitable circuitry for generating a pressure signal from the pressureapplied by fluid in the lumen of the fill-drain line 47 at its distalend. A connector 46 configured for connection to a peritoneal catheteris attached to the distal end and a connector 49 for connection to asource and/or sink of fluid is located on the proximal end of thefill-drain line 47. The connector 46 may be permanently attached to aperitoneal catheter or may have a peritoneal catheter preinstalledthereat. The connectors 49 and 46 may be sealed to isolate the lumen andthe unit 60 delivered as a sealed unit with a sterile lumen.

Referring now to FIG. 3B, a variation of a fill/drain line tubing set330 similar to the embodiment 309 of FIG. 3A has a double tube 332 withfill/drain line portion 332A having a large diameter lumen on one sideand pressure line portion 332B having a small diameter lumen 332B on theother side. Both lumens run the entire length of the fill/drain tubingset 330. Connectors 334 and 336 are provided at proximal end forconnecting the fill/drain line side 332A lumen and the pressure lineside 332B lumen to a fluid circuit and pressure sensor respectively. Apressure pod 331 is connected to convey pressure signals through thesmall lumen of the pressure line side 332B. The pressure pod 331 isconnected inline with the fill/drain lumen such that pressure is appliedto an internal diaphragm indicating pressure at the distal end of thefill/drain lumen. Note that the fill/drain tubing set 330 may be formedin various ways, for example by welding two tubes together or byextruding the two tubes with an integral web between them. Matingconnectors 326 and 324 may be provided for connecting a peritonealcatheter 322.

The embodiment of FIG. 3B may be used in the same manner as that of FIG.3A. Thus, in this embodiment also, the pressures at each end of thefill/drain line may be determined by a controller that operates thecycler at all times during operation of any suitable PD cycler andapplied as continuous input signals to the controller during fill anddrain operations.

Referring now to FIGS. 4A and 4B, a peritoneal catheter 350 has anintegrated pressure transducer 342 which is connected by embeddedelectrical leads 340 running along the catheter 350 to a terminalconnector 340. A pair of cuffs 344 is located on a proximal section 348near the proximal end which is provided with a fluid connector 352. Thepressure transducer 342 may be a strain gauge device with a flexiblehermetic wrapper that can be welded to the catheter or integrally moldedin. The connector 366 may be of any suitable type and may be connected alead 365 carried on a fill/drain tubing set 360 similar in design tothat of FIG. 3A (or that of FIG. 3B or any other suitable design). Thelead 365 may have suitable mating electrical connectors for connectionto a cycler with a controller to apply a pressure signal from thetransducer 342. The catheter 350 has openings to distribute outflow andsuction in the peritoneal cavity as in known catheters for peritonealdialysis.

A variation of any of the foregoing embodiments may be fill/drain lineswith separated fill and drain lines, each having a respective lumen. Thelines may be connected to the cycler by separate attachments, merged bya T or Y junction at the cycler, merged at the peritoneal catheter or acombination of these.

FIG. 3C shows a coextruded air line and fluid line which may be employedin an embodiment of a peritoneal fill/drain line having a patientfill-drain line and pressure pod type pressure sensor thereon. It willappreciated that such an embodiment may be readily based on theembodiments of FIGS. 3A and 3B. A coextrusion 390 has an air lineportion 389 and a fluid line 388. The fluid line 388, which may beconnected as described herein for conveying fresh and spent peritonealdialysis fluid, may be of larger diameter than an air line 389. The airline may be attached to convey pressure signals from a pod (e.g., 304 inFIG. 3A) to a transducer (e.g., 314 in FIG. 3A). In an alternativeembodiment, a patient line may have separate fill and drain lines whichmay be coextruded as a unit with the air line thus forming three lumensin a single integral structure.

Referring now to FIGS. 5A to 5C, an example process for monitoringpressure signals from the foregoing peritoneal devices is now described.FIG. 5A shows a process for storing a string of pressure signal samplesfor an interval of time. For example, the pressure signal may be sampledat 100 ms intervals for a period of 20 seconds at S12 and the processrepeated after a delay S10. The samples may be stored in a memory formany samples covering an entire treatment or for only a portion of atreatment. Alternatively to the process of FIG. 5A, pressure datasamples respective of each pressure sensor may be continuously stored ina memory and refreshed after archiving following a treatment orrefreshed in a first-in first-out fashion according to a time intervalso as to preserve only a short term historical record. In anotheralternative, only instantaneous pressure data may be stored.

The procedure of FIG. 5B derives various information from the datastored by the operation of FIG. 5A. The operation may be applied to eachpressure signal, including, for example, those provided by a distalpressure sensor (e.g., 110 of FIG. 1) and a proximal pressure sensor(e.g., 102 of FIG. 1). The procedure of FIG. 5A recovers the storedsignal segment S22 and processes it to remove noise S24 (e.g., low passfiltering, smoothing, thresholding or other suitable filtering process).At S26, the pressure signal segment is analyzed to generate areliability metric indicating its accuracy. The latter may be done invarious ways, for example, by identifying differences between a storedactual reading and a measured pressure or rate of change in pressure. Inaddition, or alternatively, the goodness of fit of the pressure profileto a stored model may provide a measure of accuracy (the curves beingfitted in S28). The pressure reading may be compared to a profile. InS28, pressure profile data is translated into a respiration rate andpulse rate by fitting expected respiration and pulse curves to thestored data and the reliability metric and analyzing.

More sophisticated analysis may be done in S28 as well, for example, byfitting the measured data curves to curves that characterizeidentifiable conditions, such as dangerous conditions. For example, aleak may be indicated by a sharp drop in pressure at the distal locationalong with a gradual trend of ebbing pressure. The profile templatesthat characterize events may be determined via experiment or modeling orsimply by judgment and stored in a memory of the controller. Otherevents that may be identified, for example by comparing distal andproximal pressure readings, are kinks or flow restrictions in thefill/drain line or changes in the properties of fluid, for example suchas may evidence peritoneal infection. The latter may be detected byidentifying an excessive pressure drop in the fill/drain line during adrain operation, which may be caused by excessive viscosity in the spentdialysate. In S30, events detected in the profile data, current pressurevalues, historical data, and reliability estimates are updated. Currentdata, for example, may be stored in a location representing currentvalues and historical data may be stored in memory locationsrepresenting historical values along with time and date values. Forexample, a memory location may hold a current estimate of patency of thefill/drain line. The event detection results may be represented asstatus flags and associated reliability estimates or other metrics suchas a measure of goodness of fit to a characteristic curve orinstantaneous value.

Referring to FIG. 5C, during a fill or drain cycle S42, the eventrecognition status and/or instantaneous values, such as those ofpressure, are read by the controller from the controller memory S44 andcompared to various threshold levels S46, S48, S50 and if the thresholdtest is met, an alarm indication may be generated S52 and the cycler maybe placed in a safe mode corresponding to the detected event orcondition. Otherwise, control may return to S42.

Archived data may be transferred to a data store for combination withdata of multiple patients, for example via an internet connection, foranalysis and comparison purposes.

The conditions detected in S46, S48, S50 may include, for example:

-   -   1. A reduction in the strength of vital signs (e.g.,        respiration, pulse) signal evidencing a line obstruction, loss        of patency of the catheter or other problem;    -   2. Excessive pressure loss for an instantaneous flow rate, which        may indicate a line obstruction, kink, or pinching of the line        or other problem;    -   3. Excessive pressure of the peritoneum which may be compensated        by reducing or stopping the flow rate;    -   4. Excessive drain flow pressure loss in the drain line due to        high viscosity which may indicate an infection.

Referring now to FIG. 6A, a peritoneal cycler system 600 generatescustom peritoneal dialysis solution according to a prescription storedin a controller 610. The prescription may be entered in the controllervia a user interface 601, via a remote terminal and/or server 603 or byother means such as a smart card or bar code reader (not shown). Thecontroller applies control signals to a fluid conveyer and circuitswitch 616 and a water purifier 620 and receives signals from distal andproximal pressure sensors 613 and 614, respectively, on a fill/drainline 650 which may be in accord with foregoing embodiments.

The fluid conveyor and circuit switch 616 is a fluid circuit elementwith one or more sensors, actuators, and/or pumps which is effective toconvey fluid between selected lines 642, 644, 646, 648, 650 and 618responsively to control signals from the controller 610. Exampleembodiments are described herein, but many details are known from theprior art for making such a device so it is not elaborated here.

A multiple-container unit 641 includes a pre-filled, pre-sterilizedosmotic agent container for osmotic agent concentrate 602 and anotherelectrolyte container with electrolyte concentrate 604. The unit 641also contains an empty batch container 606 which is large enough to holda sufficient volume of dialysis solution for the completion of at leastone fill cycle of an automated peritoneal dialysis treatment. Thecontainers 602, 604, and 606 may be flexible bag-type containers thatcollapse when fluid is drawn from them and therefore, do not require anymeans to vent air into them when drained.

Osmotic agent container 602, electrolyte container 604, and batchcontainer 606 are all connected by respective lines 642, 648, 644, and646 to the fluid conveyor and circuit switch 616. The fill/drain line(or multiple lines) 650 and a spent fluid drain line 618 with aconductivity sensor 628 may also be connected to the fluid conveyor andcircuit switch 616. The fluid conveyor and circuit switch 616 also has afill line 631 for receiving water. The water purifier 620 may be apurifier or any source of sterile and pure water including apresterilized container of water or multiple containers. In a preferredconfiguration, water purifier 620 may be configured as described inWO2007/118235 (PCT/US2007/066251) hereby incorporated by reference inits entirety and attached to the provisional application. For example,the water purifier 620 may include the flow circuit components of FIG.22A including the water purification stages and conform generally to themechanical packaging design shown in FIG. 24 of the incorporated(attached) publication.

FIG. 6B shows a preliminary stage of fluid preparation prior totreatment according to an embodiment of the disclosed subject matter.The controller 610 reads a prescription and generates a command,responsive to a treatment preparation initiation command, to flowosmotic agent concentrate from container 602 to the batch container 606.The command is applied to the fluid conveyor and circuit switch 616 toconnect the osmotic agent concentrate line 642 to the batch fill line644 and also to convey the osmotic agent concentrate into the batchcontainer 606. This may be done by one or more valve actuators and oneor more pumps that form the fluid conveyor and circuit switch 616. Thefluid conveyor and circuit switch 616 may be configured to meter thequantity of osmotic agent precisely according to a predicted amount ofdilution by electrolyte and water to achieve the prescription. Themetering may be performed by a positive displacement pump internal tothe fluid conveyor and circuit switch 616 or other means such as ameasurement of the weight of the osmotic agent container 602 or thebatch container or a volumetric flow measurement device.

In an alternative embodiment, part of the water (less than the totalused for dilution as discussed below with reference to FIG. 6C) is addedto the batch container first, before the osmotic agent and electrolytes(if needed) are pumped into the batch container.

Referring now to FIG. 6C, a dilution stage is performed using theperitoneal cycler system 600. The controller 610, in response to theprescription, generates a command, to flow purified water from the waterpurifier 620 to the batch container 606. The command is applied to thefluid conveyor and circuit switch 616 to connect the purified water line631 to the batch container 606 to add a measured quantity of water todilute the osmotic agent concentrate in the batch container 606. Thecontroller may control the fluid conveyor and circuit switch 616 toensure the correct amount of water is conveyed. Alternatively, the waterpurifier may incorporate a flow measurement device or metering pump orother suitable mechanism to convey the correct amount of water. Thecontroller 610 may be connected to the water purifier 620 to effectuatethe dilution result. The fluid conveyor and circuit switch 616 may alsobe configured to circulate diluted osmotic agent solution through lines644 and 646 either simultaneously with the dilution or after thediluting water has been transferred to the batch container according toalternative embodiments.

The relative amounts of water, osmotic agent, and electrolyte may bedefined based on the ratiometric proportioning properties of the pump.Since a single tube is used to convey all the liquids into the batchcontainer, most sources of offset from predicted pumping rate (based onshaft rotations, for example) to actual pumping rate affect all thefluids roughly equally.

Referring now to FIG. 6D, the diluted osmotic agent solution in thebatch container 606 is tested to ensure the correct concentration ofosmotic agent is achieved. In an embodiment, the osmotic agentconcentrate 602 has an amount of electrolyte concentrate to generate aconductivity signal using the conductivity sensor 628 when fluid fromthe batch container 606 is conveyed by the fluid conveyor and circuitswitch 616 to the drain line 618 past the conductivity sensor. Theamount of electrolyte pre-mixed with the osmotic agent may be lowestratio of electrolyte to osmotic agent a possible prescription mayrequire. The fluid conveyor and circuit switch 616 may perform thefunction using one or more valve actuators and one or more pumps thatform the fluid conveyor and circuit switch 616. The fluid conveyor andcircuit switch 616 may be configured to meter the quantity of waterprecisely or the function may be provided by the water purifier 620. Thecontroller may add additional water or osmotic agent and test theconductivity again if the measured concentration of osmoticagent/electrolyte is incorrect. In addition to using a combined osmoticagent and electrolyte concentrate in osmotic agent container 602, in analternative embodiment, the osmotic agent container 606 holds osmoticagent concentrate with no electrolyte and osmotic agent concentration ismeasured directly by other means such as specific gravity (hydrometer),refractive index (refractometer), polarization, infrared absorption orother spectrographic technique.

FIG. 6E shows an electrolyte addition stage of fluid preparation priorto treatment according to an embodiment of the disclosed subject matter.The controller 610 reads a prescription and generates a command to flowelectrolyte from container 604 to the batch container 606. The commandis applied to the fluid conveyor and circuit switch 616 to connect theelectrolyte concentrate line 648 to the batch fill line 644 and also toconvey the electrolyte concentrate into the batch container 606. Thismay be done by one or more valve actuators and one or more pumps thatform the fluid conveyor and circuit switch 616. The fluid conveyor andcircuit switch 616 may be configured to meter the quantity ofelectrolyte precisely according to a predicted amount of dilution byosmotic agent and water that has been previously determined to be in thebatch container 606, to achieve the prescription. The metering may beperformed by a positive displacement pump internal to the fluid conveyorand circuit switch 616 or other means such as a measurement of theweight of the electrolyte container 604 or the batch container 606 or avolumetric flow measurement device.

Referring now to FIG. 6F, the electrolyte may be mixed using the batchfill and drain lines 646 and 644 in a closed loop. If necessary,depending on how much dilution was performed during the osmotic agentdilution process, further dilution may be performed as described above.The final formulation may be achieved by the process illustrated in FIG.6F. Then, as illustrated in FIG. 6G, the final electrolyte concentrationof the mixture in batch container 606 may be determined with aconductivity sensor 628 by flowing a sample therethrough.

In addition to mass or conductance measurements, other types of measuresmay be used to measure proportions of dialysis fluid components anddilution. For example, tracer chemicals such as radioactive tracers ordyes may be used.

Although gravimetric and tracer/conductance sensing were described asdevices for ensuring proper proportioning and dilution rates forachieving target prescriptions, it should be clear that the system mayemploy ratiometric proportioning as well, particularly where positivedisplacement pumping is employed. Ratiometric proportioning takesadvantage of the volumetric repeatability and predictability of certainpumps. For example, a particular pump can deliver a highly repeatablevolume of fluid for a given number of pumping cycles (pump rotations fora peristaltic pump or cycles for a diaphragm pump, for example). If alldialysis solution components (water, osmotic agent concentrate, andelectrolyte concentrate, for example) are delivered to the mixingcontainer using the same pump, including, for example, the pumping tubesegment of a peristaltic pump, then the volume ratios of the componentswill, after adjustment for potential flow path and/or viscositydifferences as described below, be fully determined by the number ofpump cycles used to convey each component.

This proportioning may supplement or substitute for measurement of thefluid conductance or density or other measurements. To convert thenumber of pump cycles to actual displaced mass or volume, a calibrationmay be performed and/or flow path (including fluid properties)compensation parameters may be employed. The flow path compensationparameters may be respective to each particular fluid flow path and/orfluid type, or may be identical for all fluid paths and fluid types. Toprovide enhanced accuracy, one or more pump calibration and/or flow pathcompensation parameters may be generated through a calibrationprocedure. Typically, flow path compensation factors will be establishedduring the development of the system and stored in non-volatile memory.Typically, one or more flow path calibration procedures will beperformed when the system is used by a patient. The calibrationprocedure may be performed after each new fluid set is installed, orbefore each batch preparation cycle, or even multiple times during thepreparation of a single batch. A disposable fluid set may be installedevery day. The calibration procedure may be done using water. Thecalibration may sequentially pump fluid through one or more of thefollowing stages:

From To Water source Drain Batch container Drain Osmotic agentconcentrate container Drain Electrolyte concentrate container DrainPatient access Drain Batch container Patient access Osmotic agentconcentrate container Batch container Electrolyte concentrate containerBatch container Water source Batch container

In the calibration procedure, fluid is pumped between any or all of thepaths identified above. A separate calibration coefficient may begenerated for each of the paths. The calibration coefficient may bestored in a memory or non-volatile data store, for example, as aparameter representing the number of ml/per pump rotation (or diaphragmpump cycle), or as a proportionality ratio relative to a particularreference flow path. The actual fluid quantity transported during thecalibration step may be measured by any suitable device (flow sensor)including volume or mass measurement devices or direct flow ratemeasurement with integration, for example, using laser Dopplervelocimetry, thermal transit time, magnetohydrodynamics, propellerhydrometer, positive displacement flow measurement, differentialpressure through a resistance such as a venturi, nozzle, orifice plate,or other flow obstruction, variable area or rotameter, pitot or impacttube, vortex shedding frequency counting, ultrasonic, or other device. Aparticularly advantageous device for flow calibration is to measure thetransit time of a fluid property perturbation between spaced fluidproperty sensors as described below with reference to FIG. 22A. Any ofthe disclosed embodiments may employ a flow sensor in which at least theportion of which that carries fluid is disposable so that the flow rate(or total displaced fluid quantity) can be input to a controller whileallowing the use of a disposable fluid circuit. Examples include anultrasonic soft tube flowmeter made by Strain Measurement Devices SMDthat non-invasively measures flow in soft tubing by means of slottedtransducers in which a length of tubing can be inserted during fluidcircuit installation. For cartridge embodiments, the PD cycler canemploy a moving transducer stage that engages an exposed tube length ofthe cartridge after passive insertion of the cartridge.

The pumping system may also be sufficiently repeatable in a way thatallows precise ratios to be established without calibration, dependingon the predefined tolerances chosen by the system designer. If themanufacturing tolerances, including materials, are sufficientlycontrolled, a desired level of control over ratios may be achievedwithout in situ (point of care) calibration. A particularly sensitivecomponent in terms of guaranteeing repeatability is the pumping tubesegment of a peristaltic pump. In a first embodiment, the peristalticpump tube segment is made from a material whose mechanical and materialtolerances are controlled within predefined limits. The lengths of thetubing circuit elements and mechanical parameters are also controlledwithin respective predefined limits. A calibration may then be doneoutside the treatment context, e.g., in the laboratory, to calculateprecise values to convert pump cycles to fluid quantity transferred fora single lot of replaceable fluid circuits. The calibration may be donefor multiple lots. The calibration may also be done for each fluidcircuit. The calibration may also be done by the treatment system foreach fluid circuit. The calibration may also be done for each batch offluid prepared by the fluid circuit.

Referring to FIG. 6H, subsequent to the preparation of the contents ofthe batch container 606 as described above, the fluid conveyor andcircuit switch 616 may be configured to drain the patient 611 dependingon the patient's prior status. Spent dialysate fluid may be withdrawn bythe fluid conveyor and circuit switch 616 and conveyed through the drainline 618. Then, the contents of the batch container 606 may be conveyedas illustrated in FIG. 6K to the patient. Here the controller 610 hasconfigured the fluid conveyor and circuit switch 616 to flow fluid to apatient 612.

Referring now to FIG. 7A, a fluid circuit embodiment for implementingthe embodiment of FIG. 6A includes a disposable fluid circuit 700. Thefluid circuit 700 may include pre-attached osmotic agent and electrolyteconcentrate containers 760 and 762. Also, the fluid circuit 700 mayinclude pre-attached batch container 764. The contents of the osmoticagent and electrolyte concentrate containers 760 and 762 may besufficient for multiple cycles and thereby cover a complete automatedperitoneal dialysis treatment. The internal volume of the batchcontainer may be sufficient for one cycle or multiple cycles in a singleautomated peritoneal dialysis treatment.

The fluid circuit 700 is preferably a disposable unit that has acompletely sealed internal volume except for a water inlet connection730 for connection to a source of purified water, a drain connection713, and a connection for a patient access 717. The connectors 730, 713,and 717 may be sealed with a removable connector cap and the entiredisposable fluid circuit 700 sterilized as a unit. The water inlet line726 may include a sterile barrier 728 in the form of a sterile filter,for example, one with a pore size of 0.2 microns or smaller to filterout contaminants. Effectively, that leaves only the patient accessconnection 717 and the drain connection 713 as possible entry paths forcontaminants. However, the drain line 712 can incorporate a check valveto prevent inflow of fluids therethrough. It is generally a one-way pathas well, so this removes all but the patient access connection 717 as apossible route for contaminants to flow into the sealed volume of thefluid circuit 700.

The fluid circuit 700 includes fluid circuit manifold panels 702 and 704which each distribute flow along their respective lengths effectivelyallowing flow between any of the connected respective lines. Forexample, fluid from the osmotic agent line 724 can flow into themanifold 702 and be pumped through a pump line 706, which is configuredto mate with a peristaltic pump, into the manifold 704 and then into aselected one or more of the mixing line 715, drain line 714, and/orfill/drain line 716. The fluid circuit manifolds 702 and 704 may includesensor regions (not indicated).

A variety of alternative manifold and/or actuation devices can be usedto implement the methods described herein. For example, referring toFIG. 8D, a fluid cartridge 800 has two shell parts 802 and 803 thatpartially enclose a tubing set with manifold branches 806 (typ.) thatstem from manifold parts 812A and 812B. Windows 810, 805 in each shellpart 802 and 803 appear in pairs on either side of a branch 806 topermit a linear actuator (solenoid clamp, stepper and screw drive,pinching mechanism like a plier grip, or other kind of mechanism) toaccess, and selectively clamp, the segment 816 from outside the shell.

The shell housing is assembled as indicated by the dotted arrows into apartial enclosure. Alternatively the tubing parts and manifold may beattached to a single backplane or inserted in a support on a permanentmounting fixture of a PD cycler.

A window, provided by openings 804 and 815, similarly provides access toa pump tubing segment 816 by a peristaltic pump rotor. The pump tubingsegment 816 may be flanked, and also be size-matched to connectedtubing, by pressure pods 814. Pressure pods for fluid pressuremeasurement are known in the art and the details are not providedherein.

The manifolds of the foregoing figures can be realized using a varietyof structures. For example, fluid circuit part 826 uses Y-junctions 828and connecting segments 827 to interconnect tubing branches 828. Thisstructure may be used in place of manifold part 812B, for example, and avariation for manifold part 812A.

The completed device 800 may form a fluid cartridge that can inserted ina cycler housing like a slice of bread in toaster or may be attached tothe actuators in other ways.

Actuator regions 732A-732H allow the selective closing of connections toa respective line such as drain line 716. This allows any of the linesconnected to manifold 702 to be connected to a line of manifold 704through the pumping line 706 by closing all the other lines except theselected lines. In manifold 704, actuator region 732A controls access topatient access line 716. Actuator region 732B controls access to drainline 714. Actuator region 732C controls access to mixing line 715. Inmanifold 702, actuator region 732D controls access to batch fill line718. Actuator region 732E controls access to drain line 718. Actuatorregion 732F controls access to electrolyte fill line 722. Actuatorregion 732G controls access to osmotic agent fill line 724. Actuatorregion 732H controls access to the water fill line 726.

The patient access line may include a pressure sensor 735 such as apressure pod as described above with an air line 734 and a connector 736for connection to a pressure transducer on a peritoneal dialysis cycleror, alternatively, to a sensor region on the fluid circuit manifold.

Referring now to FIG. 7B, a combined fluid preparation apparatus and PDcycler 788 is combined with a water purifier 790 forming a PD system701. A disposable fluid circuit unit 758 conforms to the generaldescription of the embodiment 700 of FIG. 7A. An automated peritonealdialysis cycler 788 has a control panel 776 and is configured to use thedisposable fluid circuit 758. Various actuators and sensors (e.g.,pressure transducers, temperature sensors, optical leak detectors, etc.)are generally indicated at 772. A hatch 773 may be closed over thedisposable unit cassette 758 to bring the components thereof intoengagement with the various actuators and sensors 772.

The disposable fluid circuit unit 758 has a cassette portion 766 thatincorporates manifolds 762 and 764 (corresponding respectively tomanifolds 702 and 704 of FIG. 7A). The manifolds 762 and 764 areattached to each other but have internal flow areas that are not influid communication (isolated from each other) so that only a pump line768 allows fluid communication between the manifolds 762 and 764. Theother elements of the fluid circuit 758 are as described with referenceto FIG. 7A. The automated peritoneal dialysis cycler 788 is shown setatop a water purifier 790. The automated peritoneal dialysis cycler 788may include a tray 780 for supporting the batch container 764 and/or ascale 778 for measuring its weight. A support 782 supports the osmoticagent and electrolyte containers 760 and 762, respectively.

A registration area 770 (for example a recess area) of the automatedperitoneal dialysis cycler 788 has a peristaltic pump actuator 774. Theregistration area receives the cassette portion 766 of the disposablefluid circuit unit 758 as shown in FIG. 7C so that the pump line 768engages the peristaltic pump actuator 774 and the sensor and actuatorareas of the cassette engage the corresponding sensors and actuators 772of the automated peritoneal dialysis cycler 788.

Referring now to FIGS. 8A and 9, schematic diagrams of a peritonealdialysis system 900 and water purification system 901 are shown whichoperate together as a complete system as described in the presentspecification. The peritoneal dialysis system 900 includes a fluidmanagement set 900A. The fluid management set 900A is coupled to a fluidcircuit of the water purification system 901 which contains a permanentmodule 952 and consumable components including filter media and tubingsets 901A. The peritoneal dialysis system 900 includes a PD cycler anddialysate preparation module 949 which contains controls and much of thepermanent hardware; the water purification system may be interconnectedto share controls so that a single user interface panel 906 may be usedto control both for administration of treatment.

The PD cycler and dialysate preparation module 949 has a controller 907with a user interface panel 906. The user interface panel has controls906A, 906B, 906C and a display 906D. The controls and other features ofthe user interface panel 906 may include an audio output device, LEDlamps, touchscreen input, and other devices that may be employed forinteracting with digital electronic control systems. Preferably the userinterface panel 906 controls 906A, 906B, 906C are a small set of clearlydifferentiated controls that are color coded and shape-differentiated.

The fluid management set 900A includes disposable batch, electrolyte,and osmotic agent concentrate containers 908, 910, and 912; for example,bags that are connected to respective dialysis solution, electrolyte,and osmotic agent draw lines 916, 915, 914. The batch container 908 ispreferably an empty presterilized flexible container that is deliveredempty of air or fluid and permanently attached to the dialysis solutiondraw line and a batch fill line 917, the batch fill line 917 being usedto add fluid to the bag and the dialysis solution draw line 916 beingused to draw contents from the bag. Electrolyte and osmotic agentconcentrate containers 910 and 912 store, respectively, electrolyte andosmotic agent concentrate and are also permanently attached to osmoticagent and electrolyte draw lines 914 and 915. The containers and linesare preattached and provided in a sterile condition. The batch container908 is eventually filled with a mix of sterile water, osmotic agent andelectrolytes to form a dialysis solution prescription. The batchcontainer 908 has two lines while the other containers have a singleline. The osmotic agent and electrolyte containers 912 and 910 may befitted with non-reopening clamps 953.

The batch container 908 may be configured to accommodate sufficientdialysis solution for a single peritoneal dialysis fill cycle or it maybe large enough for multiple fill cycles. Thus a preparation cycle maygenerate enough dialysate for a complete treatment (for example anocturnal treatment cycle including multiple drain-fill cycles).

The batch, electrolyte concentrate, and osmotic agent concentratecontainers 908, 910, and 912 may rest on a heater and/or scale 902indicated by dashed lines. Temperature sensors 904 and 905 may beprovided on the surface of the heater and/or scale 902 to providetemperature signals to the controller 907, which controls the heaterand/or scale 902. The controller may be configured to warm the dialysatein the batch container 908, which rests directly on the heater and/orscale 902. The temperature sensors 904 and 905 may be positioned toensure the batch container 908 rests directly on the temperature sensors904 and 905. The combination of free convection in the large batchcontainer 908 (multiple liters), thin wall of the batch container 908,and the compliance of the wall help to ensure a reading of thetemperature sensors 904 and 905 that reflects the temperature of thecontents of the batch container 908. Note while the temperature sensors904 and 905 are shown positioned remote from the batch, electrolyte, andosmotic agent containers 908, 910, 912, it is intended that they belocated immediately adjacent to the batch container 908.

The draw lines 914, 915, and 916 and the fill line 917 connect to amanifold module 911 with two valve headers 941 and 946, separated by abarrier section 842, and interconnected by a pump tubing segment 944.The flow between the valve headers 941 and 946 occurs only through thepump segment 944 or through an external connection between the lineslinked to it, such as by flowing through the batch container 908 via thevalve headers 941 and 946 draw and fill lines 916 and 917. The manifoldmodule 911 in combination with a peristaltic pump actuator 943 and valveactuators 929, 930, 928, 931, 932, 933, 934, and 935 provides andregulates the flow of fluid between selected pairs of the tubing lines914, 915, and 916, the fill line 917, drain lines 920A and 920B, productwater line 919 and a patient line 945. The manifold module 911 also hassensor regions 936 and respective pressure transducers 924 and 925 togenerate pressure signals reflecting pressure on either side of the pumptubing segment 944.

The manifold module 911 also has chambers 913A and 913B and respectivepressure transducers 926 and 927 to generate pressure signals reflectingpressure on proximal and distal ends of the patient line 945. Thepressure chamber 913B is connected to a pneumatic signal line 909 whichis in turn connected to a pressure pod 951 configured to transmit thepressure in the patient line 945 distal end through the pneumatic signalline 909 to the chamber 913B. Chamber 913A is in communication with theend of the patient line 945 that is closest to it and conveys thepressure to the transducer 926 to generate a signal representing thepressure at the proximal end of the patient line 945. The controller 907is connected to control the peristaltic pump actuator 943 and valveactuators 929, 930, 928, 931, 932, 933, 934, and 935 and receivepressure signals from the pressure transducers 924 through 927. Themanifold module 911 may be pressed against the valve actuators 929, 930,928, 931, 932, 933, 934, and 935 by means of a door 973 which may have ahinge and latch as shown in the figures. [NOTE: see background materialsfor updated thoughts re: how this will actually be configured . . . ]

An alternative embodiment has a direct pressure-to-electrical transducerin place of the pressure pod 951, which obviates the need in suchembodiment for chamber 913B. A direct pressure-to-electrical transducermay take the form of an immersible strain gauge which is bulk-modedeformable so as to provide negative and positive pressure values oreither one as required. An electrical lead or wireless channel mayconvey a pressure signal to the controller 907. Such a transducer may beintegrated into a connector for the patient access. Alternatively, thedirect pressure-to-electrical transducer may be a pressure catheter,such as one integrated with the peritoneal catheter, as describedelsewhere in the present document.

The manifold module 911 has respective box shaped valve headers 941 and946. Each header has a plurality of valve structures that is actuated bya respective one of the valve actuators 929, 930, 928, 931, 932, 933,934, and 935. The valve actuators 929, 930, 928, 931, 932, 933, 934, and935 may be solenoid hammers, linear motors, pneumatic hammers or anysuitable device for applying a force to press on a respective one of theheader valves (one of the valves being indicated at 140). Referring toFIGS. 8B and 8C, a valve 140 is shown in an open position (FIG. 8B) anda closed position (FIG. 8C). The plunger 136 of an actuator (such as929) moves vertically to exert a force on a membrane 134 to close itover an opening 132. A tube 131 is attached by bonding to the headerwall 135 using a conforming port 133 to allow the tube 131 to bereceived and sealed to the header wall 135. The tube 131 is sealed tothe header wall 135 preventing flow between a lumen of the tube when themembrane is closed over the opening 132. An interior volume 130 of thevalve header 941 or 946 is thereby only accessible selectively byoperating the actuator to drive the plunger 13 accordingly. By selectinga pair of actuators to open, flow can occur through the interior volumeof the valve header between the lumens of two tubes corresponding to thepair of actuators that are activated to open. The actuators can benormally closed by a spring (or other means) and only opened when theactuator is energized. Alternatively they can be normally open.

The product water line 919 connects to a water purification system (linecontinues to a line labeled with the same joining symbol A in FIG. 9).The drain line 920 connects to the water purification system (the linecontinues to a line labeled with the same joining symbol B in FIG. 9. Acontrol line connection (which may be wired or wireless) indicated byconnection symbol C may be provided to connect an internal centralcontroller 959 to the controller 906 to permit commands from thecontroller 906 to be used for controlling the water purification system901. Note that alternatively, instead of a controller 959, a data bus orequivalent communication network such as a wiring harness or wirelesspiconet (not shown) may give direct access to all sensors and finalcontrollers and actuators of the water purification system 901 to thecontroller 906 so that the water purification system is simply acomponent of the peritoneal dialysis system 900. In other embodiments,the water purification system is operable as a stand-alone device andincludes its own user interface and control to supply product water forother functions such as hemodialysis. In embodiments, the functions ofuser interface 906 may be incorporated or included in wireless inputdevices such as a scale 955 or a portable user interface module 956.

A sterile filter 939 is provided to sterile-filter product waterprovided in product water line 919. During, prior to, or afterpreparation of a batch of dialysis solution, the filter may be testedfor leaks by performing a bubble point or pressure decay test. Adelta-pressure transducer (two pressure sensors separated by themembrane) or a single pressure transducer on the air side of a wettedmembrane may be used. In the present embodiment, a transducer at 919measures the pressure in an air chamber 948 which is in communicationwith an air side of a wetted membrane of the sterile filter 939. Thepressure transducer 919 is used to detect pressure decay (or in otherembodiments, a transmembrane pressure TMP decay profile) to determine ifthe filter integrity is within expected limits. In the presentembodiment, an air pump 917 draws air through a filter 921 andselectively pumps it through a control valve 923 and a pressure sensor.The pump 917 may run continuously using a pressure regulated valve 918to maintain a desired pressure supply to the valve 923 and the valve 922which may be opened selectively to deliver air into chamber 913B and/or948. The purpose of flowing air into chamber 948 is to perform a bubbleor pressure decay test which is done after making a batch of dialysissolution and to confirm that the filter integrity was maintained duringtransfer of product water. The flowing of air into chamber 948 is donefor the purpose of resetting the volume of the air-side chamber of thepressure pod 951. Air may be selectively leaked from and pumped into thepressure pod to avoid the diaphragm being pinned against one side or theother of its range of travel thereby preventing false readings. So tosummarize, valves 918, 923, and 922 are controlled by controller 907 toregulate pressure (by bypassing flow), and selectively allow air to flowto chambers 913B and/or 945 for the described functions.

Referring now particularly to FIG. 9, the water purification system 901purifies water through a first stage that employs a coarse particulateand/or sediment trap 994. A second stage employs a carbon filter. Athird stage uses an ultraviolet lamp to decontaminate water. A fourthstage employs reverse osmosis. A fifth stage uses a carbon polishingfilter which is followed by a sixth stage of deionization filtration. Aseventh and final stage is a sterilization stage employing a pair ofultrafilters connected in series, which prevents grow-throughcontamination of the final product water.

A permanent filtration subsystem 952 contains a pump, 990 theultraviolet lamp 982, sensor modules 984 and 985, automatic shutoffvalve 988 for the reverse osmosis system, pressure sensors 992, 981,953, 989 and valves 991 and 993.

Drain fluid from drain line 920 passes through a connector 978 and intoa pair of sensor modules 984 and 985 which detect and measureconductivity and temperature, respectively. The sensor modules 984 and985 provide redundancy as a protection against an error in one of themodules. Safety may be ensured, for example, by enforcing a requirementthat the serially interconnected sensor modules 984 and 985 providesignals that are always in agreement and in the event of a disagreement,depending on the operating state, an alarm may be generated or someother action taken. A urea sensor 953 may be used to generate a signalindicating level of urea. The drain line in some modes carries spentdialysate and urea content can be recorded or otherwise used to ensurecorrect treatment of renal dialysis patients according to knownprinciples. The urea level may be displayed on the display 906D orrecorded in a data store of the controller 907 or stored also oralternatively on an Internet server or other external data store (notshown). Check valves 987 at various locations prevent backflow. Onecheck valve 987 in the drain line may be used to prevent backflow intothe peritoneal dialysis system 900. Another check valve 987 preventsdraining fluid backflowing into reverse osmosis filters 975 and anotherprevents prefiltered water flowing from the reverse osmosis filters 975from flowing in reverse. Another check valve 987 prevents primary waterentering the system upstream of the particle filter 994 from flowing inreverse.

In addition to the sensor modules 984 and 985, or alternatively, a fluidquantity measurement module may be provided. Primary water enters thewater purification system 901 through a connector 978 and check valve987 and into a particle filter 994. Filtered water passes through apressure control valve 996, through air vent 999 to a connector 978connecting it to the permanent filtration subsystem 952. A speedregulated pump 990 draws water through a valve 993. Pressures, upstreamand downstream of the pump 990, are measured by sensors 992 and 989respectively. A bypass valve 991 allows water to be recirculated tocontrol pressure. The bypass valve 991 is controlled by the controller955 to regulate pressure exiting the pump 990.

An automatic shutoff valve 988 feeds water to the carbon and ROsubsystem 997 with respective waste water connection, product waterconnection and feed water connections 978. Feed water passes through aconductivity sensor 977, which applies a conductivity signal to thecontroller 955, and then through an activated carbon filter bed.

After passing through RO membranes 975, product water flows throughcheck valve 987 through a line 957 to a pressure sensor 981, through theautomatic shutoff valve 988 to an ultraviolet filter after which productwater leaves the permanent filtration subsystem 952 through a connector978. The connector 978 receiving product water from the permanentfiltration subsystem 952 is a part of a disposable filter module 970containing carbon 963, segregated bed deionization filters 959 (eachwith a cation bed 965 and an anion bed 964) and a mixed bed deionizationfilter 966. The disposable filter module 970 also contains a pair ofseparated ultrafilters 958 with air vents 956. Conductivity sensor 968Adetects early breakthrough of contaminants which may be used by thecontroller 955 to generate an indication that the filter module 970needs to be changed. The indication of expiration of the filter module970 may be output via the user interface panel 906 or an independent one(not shown). The ultrafilters 958 are separated to sterilize and preventgrow-through contamination. A check valve 969 prevents back flow. A fuse960 is blown when the filter module 970 is first connected. Thecontroller 955 prevents the reconnection of filter modules 970 withblown fuses, thereby preventing reuse of previously used filter modules970. A wetness sensor 938 is connected to the controller 955 andgenerates a signal, applied to the controller 955, when a leak wets it.

FIG. 10 shows the peritoneal dialysis system 900 reconfigured as aperitoneal dialysis system that uses prepared dialysate in presterilizedcontainers 1002. Unlike the system 900, the present system does notrequire water purification system 901 in order to work. Fresh dialysissolution bags 1002 are connected to a tubing set 1000 which isconfigured to allow the PD cycler and dialysis solution preparationmodule 949 to be used with prepared bagged dialysate. The PD cycler anddialysis solution preparation module 949 will not be described againexcept to note that the functions of the actuators 929, 930, 928, 931,932, 933, 934, and 935 are in some instances reassigned by the commandsignals of the controller 907.

As may be seen, lines 1010, 1011, 1012, and 1013 connect the dialysissolution bags 1002 to the manifold module 911. At least one of thedialysis solution bags 1002 is attached to a different one of the twovalve headers 941 and 946 to allow transfer of dialysis solution betweenbags, which in turn may allow priming of the tubing set 1000 and otherfunctions. Also note that line 1010 is coupled to the line 945 to allowfluid from either of valve headers 941 and 946 to be pumped into thepatient line 945. The functions enabled by this configuration include,for example, to allow fluid to be conveyed to one of the dialysissolution bags 1002 indicated at 1020 which may be rested on the heater903, from any of the other bags 1002. Then, once bag 1020 is emptied,fluid can be transferred from one of the other bags 1002 to fill it andthe bag 1020 heated prior to infusion. Inspection of the tubing set 1000and valve headers 941 and 946 make it clear that these functions areenabled simply by appropriate sequencing of the 929, 930, 928, 931, 932,933, 934, and 935. Each of the dialysis solution bags 1002 is providedwith a non-reopenable clamp 1005, a needle free port 1007, and matingconnectors 1006 and 1007 on the bag 1002 and tubing set 1000.

FIG. 11 shows an overview of a method for preparing any of the foregoingperitoneal dialysis systems. The left side of the flow chart of FIG. 11shows a method for systems using bagged dialysis fluids and the rightside for ones that prepare dialysis fluids such as system 900. First newbags are hung S10 (in the embodiment 902, one of the bags is placed on aheater). Then a cartridge or tubing set is loaded on the cycler S12. Inbagged fluid systems, the new bags are connected to the tubing set orcartridge S14 and the drain and patient lines connected S16. The bag1020 on the heater is used for the first cycle and may be pre-filled. Inan alternative embodiment the bag on the heater is initially empty andforms a preattached part of the fluid circuit 1000. Later after thefirst cycle, the bag on the heater may be empty and this bag may befilled from one or more of the other bags 1002. Whether filled or not,the bag on the heater 1020 is used for priming S17 by flowing dialysissolution through the fluid circuit and the patient lines S19. Fluid maybe directed through the drain during priming and for testing theconductivity as discussed above.

At S18, a self-testing procedure may be performed, for example, to do apump calibration, check pressure ranges, perform bubble point orpressure decay tests on the sterile filter membrane, etc. The patientaccess is then connected to the patient line and a drain cycle S22followed by a fill cycle S24 performed. The drain and fill cycles may berepeated until a treatment completed check S26 indicates that a completeset of drain and fill cycles has been performed. Remaining fluid in thebags 1002 may be drained S28 and the access, bags, and fluid sets may bedisconnected and disposed of S30 and S32.

Still referring to FIG. 11, a method for the peritoneal system 900 canprepare each batch of dialysate. In the method, the fluid management set900A is loaded on the system including placing the disposable batch,electrolyte, and osmotic agent concentrate containers 908, 910, and 912on the heater and/or scale 902 S40. The remainder of the fluidmanagement set 900A including the manifold module 911 is loaded and thedoor 973 closed to clamp the manifold module 911 against the valveactuators 929, 930, 928, 931, 932, 933, 934, and 935. Alternatively, anyother suitable fluid circuit, such as the examples of FIGS. 8D and 8Eand variants thereof, may be loaded. At S16, the patient and drain linesare connected and at S46, S48, the fluid circuit 900A is primed andflushed if required. The disposable batch, electrolyte, and osmoticagent concentrate containers 908, 910, and 912 connecting lines areprimed S50 and the batch preparation and filter test performed S52. Thepatient lines are primed S19 and the patient access connected S20. Thedrain and fill cycles may be repeated until a treatment completed checkS26 indicates completed set of drain and fill cycles have beenperformed. The disposable batch, electrolyte, and osmotic agentconcentrate containers 908, 910, and 912 are emptied S58 anddisconnected S60 and the drain disconnected at S32.

FIG. 12 shows details of the process within S50 of FIG. 11 in which thedisposable batch, electrolyte, and osmotic agent concentrate containers908, 910, and 912 connecting lines are primed. At S50B, the osmoticagent line 914 is filled and drained through the conductivity cell untilthe conductivity cell shows the presence of fluid at which point S50A,the same is done at S50D for the electrolyte line 913 until electrolyteis detected by the conductivity sensor at S 50C. Recall thatconductivity sensors 984 and 985 may be used for this purpose bydetecting fluid properties in the drain line connected to waterpurification system 901. Next S50F pure product water flushes out anyconcentrate fluid priming the drain line and, primes the product waterline 919 until the lapse of a time interval S50G and the conductivity ofthe product water is confirmed. The batch fill line 919 is then primedand the batch container 908 filled with 200 ml water or more S50G. Wateris drained out of the batch container 908 through the batch containerdraw line 916 until 100 ml has been removed S50J. In an embodiment, avacuum may be applied in the batch container 908 at this point tooptimize repeatability in fluid draw cycles.

FIG. 13 shows details of the process within S52 of FIG. 11 in which abatch of dialysate is prepared by the peritoneal dialysis system 900 orsimilar system. At S52B the batch container 908 is filled with productwater until 1500 ml are displaced, which is detected at S52A. Thequantity is an example only and may vary in different embodiments.Osmotic agent concentrate is then 52D drawn and pumped into the batchcontainer 908 until the total mixed volume of the batch container is1550 ml 52C. The fill state of the batch container may be confirmedvolumetrically or gravimetrically or any other suitable means. Asdiscussed above, in other embodiments, or the present embodiment, theratios of fluids are what is primarily important in terms of forming atarget prescription and the ratiometric proportioning of the presentsystem, as described elsewhere, ensures the electrolyte and osmoticagent ratios and dilution rates are achieved, in addition to, or as analternative to control or confirmation by detection. Next at S52Felectrolyte concentrate is drawn and pumped into the batch container 908until the total mixed volume of the batch container is 1650 ml 52E. Asdescribed above, optionally a mixing step followed by testing of theconductivity may be performed at this point. The batch container 908contents may be mixed by drawing and filling through lines 916 and 917for a period of time S52J or over a predefined number of pump cycles.The mixing may occur multiple times with a rest interval between mixingcycles. This may be followed by additional supplementation ofelectrolyte to achieve the desired prescription. The remaining productwater is pumped into the batch container 908 S52H until at S52G the fillquantity is achieved. At each of S52C, 52E, and 52G the conductivity ofthe contents of the batch container 908 may be checked, for example, byautomatically draining a small sample through the drain of the waterpurification system 901. Then the batch container 908 contents are mixedby drawing and filling through lines 916 and 917 for a period of timeS52J or over a predefined number of pump cycles. The mixing may occurmultiple times with a rest interval between mixing cycles. Conductivityis confirmed and the procedure ends (S52 End) or if the conductivitytest fails (dialysate conductivity not achieved) an alarm is outputS52L. Lastly, the sterile filter integrity is tested with a bubble pointor pressure decay test by pumping air through the membrane S61.

FIG. 14 shows details of the process within S61 of FIG. 11. At S61Bvalve 923 is opened, 918 closed, and air pressure increased asregistered by pressure sensor 919 until, at S61A, pressure reaches apredetermined pressure (e.g., 45 psi) then the air pump is turned offand the valve 923 closed. At S61D, pressure is monitored (and may beprofiled to generate a decay curve) as indicated by pressure sensor 919for an interval of time, for example 3 minutes S61C. If the pressurefalls below a threshold (e.g., 40 psi) an alarm is output S61F and ifnot (S61C) the valves 918 and 923 are opened until at S61E the pressureat 919 is detected to be below a threshold, for example 10 mm Hg.

FIG. 15 shows the process details of S19 of FIG. 11. FIG. 16 showsdetails of S58 of FIG. 11.

FIGS. 17A-17H, 17J-17N, and 17P-17T illustrate the method and basicstructure of the peritoneal dialysis system according to the foregoingsystem embodiments. A batch container 202 has a batch container fillline 222 and batch container draw line 224. An osmotic agent concentratecontainer 204 has an osmotic agent concentrate draw line 220. Anelectrolyte concentrate container 206 has an electrolyte concentratedraw line 218. A purified water source 216 such as a water purificationplant has a purified water supply line 223 which feeds water to asterile filter 210 connected by a sterile water supply line 226connecting the sterile filter 210 to a manifold/pumping arrangement 208.A primary drain 228 sends waste and priming fluid to a conductivitysensor 212 and out through a final drain line 230. A patient line 234 isconnected to the manifold/pumping arrangement 208.

The following description applies to a generic PD system and theelements can be configured according to any of a variety of design andtechnology approaches. For example, the manifold/pumping arrangement 208may pump fluid using a diaphragm arrangement or a centrifugal pump andincorporate flow control of any of a variety of sorts includingpermanent valves, flow switches, line clamps etc. The containers batchcontainer 202, osmotic agent concentrate container 204, and electrolyteconcentrate container 206 may be rigid or bag type containers and may bedisposable or permanent with a sterilization plant provided therewith.In any of the embodiments described herein, for example, pump/flowselector 1110, and others, the pumping and flow switching portion may bereplaced by a permanent device with connectors for disposable containerssuch as (as described with reference to FIG. 23A) the batch container(1112) and the sources 1102-1108, and patient line 1153. The drain lineand condo cell may be permanent as well. The pump/flow select device mayincorporate a sterilization unit and be configured to self-sterilizeautomatically.

In any of the embodiments disclosed herein, instead of a waterpurification plant being used as a source of sterile water, bags ofsterile water may be used. This may be advantageous where the provisionof a water source is difficult or delivery of purified water is easier,and permits the use of the same type of disposable concentrate unit andother components as described herein. In addition, a patient may storecontainers of water for travel. The long term storage of water may besafer or otherwise desirable than the long term storage of prepareddialysate. Also, rather than using prepared dilute dialysate forstorage, which has a permanent relative concentration of componentconstituents (the prescription), the use of water from containers fortravel permits the prescription to be established at the time oftreatment irrespective of when the water was delivered or used. Baggedwater may be preferred because it has a longer shelf life and is notsusceptible to precipitation as are some forms of prepared dialysate.The system as described with inline sterile filters may also providefinal sterilization of the water so that pure, but not necessarilysterile, water is provided and used. In embodiments, preferably, thewater in containers is sterile.

Referring to FIG. 7D, a PD cycler/fluid preparation component 791attaches to a disposable 792 that includes concentrate and othercomponents as described herein. One or more water containers 793 areconnected to the PD cycler/fluid preparation component 791. Thedisposable 792 includes a prepared dialysate batch container which isfilled with prepare dialysate according to prescription as describedherein with respect to any of the other embodiments. The disposable 792may include a patient line and a drain line. The water container may beprovided in bags as currently used for prepared dialysate.

In embodiments of the disclosed subject matter, pure water incontainers, such as bags, and a concentrate disposable as described inconnection with any of the embodiments are delivered to a treatmentlocation such as a home. The stored water containers and disposable areattached to a fluid preparation system and used to prepare dialysate fortreatment as described in connection with any of the disclosedembodiments. The connection for water is the same as for a waterpurification plant in the other disclosed embodiments. The operation ofthe dialysate preparation system is essentially the same as described inconnection with the various embodiments.

In embodiments of the disclosed subject matter, pure water incontainers, such as bags, and a concentrate disposable as described inconnection with any of the embodiments are delivered to a storagelocation such as a home. The stored water containers, concentratedisposable, and fluid preparation device and cycler travel with thepatient on a trip. At treatment locations, such as a hotel room, thewater containers and disposable are attached to a fluid preparationsystem and used to prepare dialysate for treatment as described inconnection with any of the disclosed embodiments. The connection forwater is the same as for a water purification plant in the otherdisclosed embodiments. The operation of the dialysate preparation systemis essentially the same as described in connection with the variousembodiments.

FIG. 17A shows the initial priming of the osmotic agent concentrate drawline 220, manifold/pumping arrangement 208 via the primary drain 228 andfinal drain line 230 through the conductivity sensor 212 as describedabove. The manifold/pumping arrangement 208 is configured to provide theflow shown and a controller is provided to change over to the nextconfiguration. In FIG. 17B the manifold/pumping arrangement 208 isconfigured to flow electrolyte concentrate from electrolyte concentratecontainer 206 priming electrolyte concentrate from the draw line 218 viathe primary drain 228 and final drain line 230 through the conductivitysensor 212. In FIG. 17C, water is moved by manifold/pumping arrangement208 from the purified water source 216 through purified water supplyline 223, through sterile filter 210, through 226, and out ofmanifold/pumping arrangement 208 via the primary drain 228 and finaldrain line 230 through the conductivity sensor 212, thereby flushingconcentrate from the manifold/pumping arrangement 208 and the primarydrain 228 and final drain line 230. At each stage, conductivity ismeasured by conductivity sensor 212 and compared to a reference range.If the value is outside the reference range, the production is haltedand an error message is generated.

FIG. 17D shows the initial filling of the batch container 202. Purifiedwater is pumped by manifold/pumping arrangement 208 through purifiedwater supply line 223, sterile filter 210, and sterile water supply line226 into batch container 202 until a predefined small volume istransferred (for example 200 ml). Osmotic agent concentrate draw line220 and electrolyte concentrate draw line 218 remain primed as shown bythe fill pattern. Next, in FIG. 17E, some of the contents (e.g. 100 ml)of the batch container 202 are drained by manifold/pumping arrangement208 out via the primary drain 228 and final drain line 230 through theconductivity sensor 212 and the conductivity determined and subsequentcontrol processing continues (halts and alarms) depending on the result.In FIG. 17E, the manifold/pumping arrangement 208 is configured topartly fill the manifold/pumping arrangement 208 by drawing water fromthe purified water source 216 through sterile filter 210 and sterilewater supply line 226 and finally into the batch container 202 via batchcontainer fill line 222. The batch container draw line 224, osmoticagent concentrate draw line 220, and electrolyte concentrate draw line218 remain primed as do the primary drain 228 and final drain line 230.

In FIG. 17G, a sample from the batch container 202 is drawn bymanifold/pumping arrangement 208 and drained via the primary drain 228and final drain line 230 through the conductivity sensor 212. Again, thefluid properties are verified by the conductivity sensor 212 and passedor alarmed. In FIG. 17H, osmotic agent is drawn from osmotic agentconcentrate container 204 via an osmotic agent concentrate draw line 220by manifold/pumping arrangement 208 and pumped into batch container 202through batch container fill line 222. In FIG. 17J, a sample from thebatch container 202 is drawn by manifold/pumping arrangement 208 anddrained via the primary drain 228 and final drain line 230 through theconductivity sensor 212. Again the fluid properties are verified by theconductivity sensor 212 and passed or alarmed.

In FIG. 17K, electrolyte is drawn from electrolyte concentrate container206 via electrolyte concentrate draw line 218 by manifold/pumpingarrangement 208 and transferred to batch container 202 via batchcontainer fill line 222. In FIG. 17L, a sample from the batch container202 is drawn by manifold/pumping arrangement 208 and drained via theprimary drain 228 and final drain line 230 through the conductivitysensor 212. Again the fluid properties are verified by the conductivitysensor 212 and passed or alarmed. In FIG. 17M, purified water is drawnby manifold/pumping arrangement 208 through purified water supply line223, sterile filter 210, and 226 and transferred to batch container 202via batch container fill line 222. In FIG. 17N, a sample from the batchcontainer 202 is drawn by manifold/pumping arrangement 208 and drainedvia the primary drain 228 and final drain line 230 through theconductivity sensor 212. Again the fluid properties are verified by theconductivity sensor 212 and passed or alarmed.

FIG. 17P shows a fluid mixing configuration in which themanifold/pumping arrangement 208 is configured to circulate fluidthrough batch container 202 via the batch container fill line 222 andbatch container draw line 224. This is done for a predefined period oftime, predicted number of fluid cycles or number of pump cycles. In FIG.17Q, a sample of the final dialysate product from the batch container202 is drawn by manifold/pumping arrangement 208 and drained via theprimary drain 228 and final drain line 230 through the conductivitysensor 212. Again, the fluid properties are verified by the conductivitysensor 212 and passed or alarmed. If the fluid formulation needs to beadjusted, a small amount of osmotic agent concentrate or electrolyteconcentrate or diluting water can be added and the test repeated untilthe desired formulation is reached.

FIG. 17R shows fluid drawn by manifold/pumping arrangement 208 throughbatch container draw line 224 and out the patient line 234 to prime thelatter. In FIG. 17S the access for the patient 214 has been connected tothe patient line 234 and a drain operation is performed in which spentdialysate is drawn from the patient 214 through the patient line 234 bythe manifold/pumping arrangement 208 and passed out through via theprimary drain 228 and final drain line 230 through the conductivitysensor 212. Detected conductivity and pressure change can be used todiagnose problems such as the permeability of the peritoneal membrane,infection, etc. as discussed above. FIG. 17T shows a patient fill cyclewhere fluid is drawn from the batch container 202 by themanifold/pumping arrangement 208 and pumped into the patient line 234and into the patient 214.

In the embodiments of FIGS. 17A-17H, 17J-17N, and 17P-17T, themanifold/pumping arrangement 208 may include a controller, userinterface, valves, one or more pumps, sensors, flowrate sensors,volumetric displacement sensors, and/or other components to achieve thestated functions.

In any of the foregoing embodiments, the osmotic agent concentrate mayinclude a predefined portion of electrolyte concentrate permitting thequantity or concentration of osmotic agent to be determined by measuringthe electrolyte concentration using a conductivity cell. The finalelectrolyte concentration is achieved by proportioning the electrolyteconcentrate based on the known amount delivered with the osmotic agentconcentrate.

FIG. 18 illustrates a control system according to embodiments of thedisclosed subject matter. A controller 830 may receive sensor signalsfrom any points in a PD system 838 including conductivity, temperature,and flow rate. The controller may apply actuator control signals toregulate the speed of pump or an equivalent flow rate regulator such asa fixed rate pump with a variable recirculation bypass line or variableinline resistance such as a flow regulator valve. Fluid provided fromthe PD system 838 is transferred at a regulated rate to a peritonealline 842, which may include a single line used for outgoing and returnfluids or a pair of lines, each used respectively for outgoing andreturn fluids. A pressure sensor 834 generates signals indicating thepressure at a distal point in an outgoing peritoneal line or aperitoneal line that transfers fluids in both directions. An additionalpressure sensor may be used for outgoing and return lines, respectively.A data store 836 may store one or more treatment profiles specific to adisposable unit that includes a fluid circuit (which may vary accordingto characteristics of the fluid circuit), specific to a particularpatient or class of patients, or other requirement.

Pressure profile data stored on data store 836 may be obtained from adata store 841 attached to the disposable unit or may be downloaded froma server based on identifying information on such a data store 841.Alternatively pressure profile data may be stored on the 836periodically and specific data to be used for a treatment selected froma user interface of the controller during treatment, for example datafor a particular patient identified through the user interface and whoseprofile data is obtained from a repository of patient-specific treatmentdata. The pressure profile data may include a single pressure valuerepresenting a maximum pressure at the point of the pressure sensor 834indicating a maximum pressure and serving as a limit on the pumping rateby pump 840 as controlled by the controller 830 as described accordingto any of the foregoing embodiments. The pressure profile data mayinclude multiple pressure values representing respective phases of aperitoneal dialysis fill cycle. For example, the pressure values maycorrelate volume and pressure or number of pump rotations and pressurethus defining a profile. In example, the rate may be rampedprogressively up toward a maximum and then slowed gradually to balancethe desires of speedy throughput and patient comfort.

FIG. 19 shows a fluid path and actuator layout according to embodimentsof the disclosed subject matter. The present embodiment shows variationson the embodiments described above. For example, separate fill 861 anddrain 862 lines are connected to the patient (a single lumen or duallumen peritoneal catheter). A sterile filter 860 is provided in the fillline. One or more flow sensors may be provided, for example as shown at854 and/or 855, which may be used for error condition detection or forimplementing a calibration procedure to derive the conversion of pumpcycles to net displaced mass or volume respective of each flow path, asdescribed above. Respective valves G1, P1, P1, P2, S1, S1, W1, and E1control the flow of fluids in the circuit. A pump 858 moves fluid in thecircuit. The following table shown an embodiment of an operationalprocedure for the embodiments covered by FIG. 19. Any of these featuresmay be combined in any of the foregoing embodiments to form additionalembodiments. For example, the one or more flow sensors may be providedin the embodiments of FIGS. 6A to 6K or 7A to 10, or 17A-17H, 17J-17N,and 17P-17T. The method embodiments may be modified to add thecalibration procedure outlined above as well.

Mode Pump Valve State Description Operation G1 E1 W1 S1 S2 P1 P2 D1 1.Prime Do until A O X X X X X X O Osmotic pump cycles agent 2. Prime Dountil A X O X X X X X O Electrolyte pump cycles 3. Prime Water Do untilB X X O X X X X O to Drain pump cycles (flush concentrate) 4. PrimeWater Do until C X X O O X X X X to SAK pump cycles 5. Prime Mixing Dountil D X X X O O X X X Circuit pump cycles 6. Prime SAK Do until E X XX X O X X O to Drain pump cycles (measure flow rate) 7. Prime Patient Dountil F X X X X O X O X Line (V1) pump cycles 8. Prime Patient Do untilG X X X X X O X O Line (V2) pump cycles 9. Add Osmotic Do until H O X XO X X X X agent to SAK (calc) pump cycles 10. Add Do until I (calc) X OX O X X X X Electrolyte pump cycles to SAK 11. Add Water Do until J(calc) X X O O X X X X to SAK pump cycles 12. Mix Do until K X X X O O XX X (calc) pump cycles 13. Test Sample Do until L X X X X O X X O (Temp/pump cycles Condo/Flow) 14. Rinse Fluid Do until O X X X X O X X O Pathpump cycles w/Dialysate 15. Drain Do until N X X X X X O X O Patient(calc) pump cycles OR PRES > Fill_Pres_ Limit 16. Fill Patient Do untilM X X X X O X O X (calc) pump cycles OR PRES > Drain_Pres_Limit 17.Patient Do until TIME — — — — — X X — Dwell COUNT 18. Empty Do until P XX X X O X X O batch (calc) pump container cycles

In the second column, Pump Operation, the letters A, B, C, etc. refer topredefined values. For example, a peristaltic pump may rotate once forevery 2 ml. pumped so the values may correspond to an amount of fluidpumped. The columns labeled Valve State refer to the status of the valveas labeled in FIG. 19, with X referring to a closed condition and Oreferring to an open condition. The term (calc) in the Pump operationcolumn indicates that the number of pump cycles is adjusted according toa parameter obtained from calibration as discussed above.

Any of the above systems may be modified so that an additional line isprovided in the fluid circuit, and valved in the same way as the batchcontainer but which leads to an auxiliary port. At the end of acycler-assisted treatment cycle, a batch of fresh dialysate may beprepared and dispensed from this auxiliary port for use in continuousambulatory peritoneal dialysis. In this system and method, the patientmay end a cycler-assisted treatment, for example, a nocturnal treatment,with a filled peritoneum. After filling the peritoneum, an additionalbatch of dialysate may be prepared and pumped from the batch containerto a secondary container through the auxiliary port. This may then beused for a second cycle of CAPD after draining the spent dialysis withwhich the peritoneum was filled at the end of the cycler-assistedtreatment phase. It should be readily apparent how an additional valveand connector on the treatment/fluid preparation device may be includedin, for example, manifold module 911 (FIG. 8A), to allow fluid to beconveyed from the batch container as required for implementation. Thecontroller of the treatment/fluid preparation device may be configuredto perform this function automatically at a user's specified optionwhich may be indicated through a user interface selection. Multiplebatches for CAPD may also be dispensed in this manner. In addition, thebatch container may be large enough for the mixing enough dialysate forone or more CAPD treatment cycles on top of the last batch used forfilling the peritoneum after completion of the phase of cycler-assistedperitoneal dialysis. In this way, the one of more CAPD batches may beprepared while the patient is still connected to the cycler andundergoing cycler-assisted therapy.

In any of the disclosed and/or claimed method, control, or systemembodiments, in which the batch container is emptied, a negative pumpingpressure may be applied to the container for a period of time to ensurecomplete emptying. Also, in any of the disclosed and/or claimedembodiments, the batch container may be positioned on an angled basewith its drain opening at a lowest point, also to help in fully emptyingthe batch container. Other embodiments may be formed by providing amechanism for jostling or vibrating the batch container and/or the otherfluid containers to help ensure fluid is not trapped.

In any of the embodiments, additional embodiments may be formed by meansof the following revision. Instead of a batch of dialysate sufficientfor performing a single peritoneum fill, the batch containers may bemade large enough for two or more fill/drain cycles. In fact, the batchcontainer may be large enough for all the required dialysate for allcycles of, for example, a full nocturnal treatment, at once. This may bedone, for example, before or while the patient falls asleep with theadvantage that the patient need not be awakened by the noise of fluidpreparation.

In any of the foregoing manifold embodiments, the drain line can besplit to valves on both sides of the pump tube, as in the embodiments ofFIGS. 7A, 7B, and 8A or the patient line can be split to valves on bothsides of the pump tube as in FIGS. 10 and 19. When the drain line issplit, the pump may need to be reversed in order to fill and drain thepatient's peritoneum. By splitting the patient line, the manifold andpump can be constructed and operated so that the pump only needs to runin a single direction in order to provide all of the required functionsaccording to embodiments in which: (1) the water, treatment fluidcomponents, and one batch container outlet are all connected throughrespective control valves to the pump inlet and the batch inlet anddrain are connected through respective control valves to the pump outletand (2) the patient line is connected to both the pump inlet and outletthrough respective control valves. By running the pump in a singledirection, the repeatability of the conversion from pump cycles tofluids transferred can be better maintained. In an alternativeembodiment, fluid is drained from the patient by a separate pump line.This may be done by a dual lumen peritoneal line or by a single lumenline.

In any of the foregoing embodiments, separate fill and drain lines canbe used instead of a single fill/drain line. In embodiments withseparate fill and drain lines, a pressure pod may be carried on the fillline alone, the drain line alone, or pressure pods may be provided onboth the fill and the drain line. The same is true for other pressuremeasurement embodiments of peritoneal treatment lines. As will beevident, the pressure measurement capabilities may be used for thedetection of spent dialysis fluid properties and for the regulation offilling flow rate and other purposes described herein.

In the present and any of the other embodiments, a sufficient amount offluid may be drained in order to contact the conductivity sensor to forma reliable reading. For example, an amount in the range of 25 to 100 mlor preferably an amount in the range of 50-70 ml. may be used.

In any of the described embodiments, the osmotic agent may be, orinclude, glucose, L-carnitine, glycerol, icodextrin, or any othersuitable agents. Further, the components combined to make a peritonealdialysis solution may vary in number and any of the embodimentsdescribed could be made from single concentrate components or any othernumber of concentrate components by straightforward modifications of theembodiments. For example, a buffer (e.g., acetate, bicarb, lactate) maybe separate from an electrolyte which may be separate from an osmoticagent.

In any of the disclosed embodiments that employ direct attachment ofdiluted fluids, for example, the embodiment of FIG. 10, sterile filtersmay be preinstalled on fluid lines, (e.g., lines 1010, 1011, and 1012)to prevent touch contamination from causing contamination of the fluidthat flows to the patient.

In any of the disclosed embodiments, pressure signals at proximal anddistal ends of the peritoneal line may be generated while a no-flow, orlow-flow, condition exists. This may be controlled to occur at a certainpoint in preparation for, or during treatment, to generate indicationsof static hydraulic head in the line. For example, if a patient fallsout of bed, and a sudden height difference between the proximal anddistal ends arises, a pressure difference may be detected. The detectionmay trigger an alarm or other output and may instantiate a change inmachine status for example a shutdown. Another inference from an out ofbounds pressure difference during low or no flow is abnormal set up ofthe system. In embodiments, the conversion of pump cycles to totaltransferred flow may be governed by assumed system configuration whichmay include a certain range of height differences between the proximaland distal ends of the peritoneal line. The following table shows somepossible behaviors.

Machine status Detected conditions Response Low or no flow DP outsiderange A Generate alarm indicating (e.g., dwell) misconfiguration. FillDP outside range B Generate alarm indicating misconfiguration Fill DPoutside range C Adjust flow rate and/or shut down flow. Drain DP outsiderange D Generate alert message indicating possible infection. Drain DPoutside range E Generate alarm indicating misconfiguration Drain DPoutside range F Adjust flow rate and/or shut down flow. Any time theline Pulse or respiration Indicate status of connection is filled withfluid detected, or stronger is ok. than threshold G, at Proximal sensorAny time the line Pulse or respiration Indicate connection is is filledwith fluid not detected or weaker misconfigured or possibly thanthreshold G at misconfigured. Proximal sensor and is detected at distalsensor Dwell Pulse or respiration Indicate status of connectiondetected, or stronger is ok. than threshold H, at Proximal sensor DwellPulse or respiration Indicate connection is detected, or weakermisconfigured or possibly than threshold H, at misconfigured. distalsensor Any time line Pulse or respiration Indicate line is misconfiguredis filled with fluid detected at distal or possibly misconfigured.sensor and not at proximal sensor Fill Proximal P high, Indicateobstruction between distal P low

In the table above, ranges identified by letter may represent pressureprofiles, that is pressure values (upper and lower limits or just upperor just lower limits) that change during a progressive process. Forexample, pressure range C may ramp up with the number of pump cycles.The range data may be stored in a memory of the controller and/or may bestored on a memory device of the replaceable tubing set and/or may beread from a remote server or derived by any other suitable system. Thepressure range data may be respective to a particular tubing set model,treatment type, and/or patient and selection may be automated or mademanually through a user interface. The term misconfiguration can referto kinks, obstructions, leaks, disconnections, or other types of lineproblems. In the table, anywhere alarm or other output is indicated asan action, this may include, or be in the alternative, instructing theuser to take some action to verify the problem or a detailed explanationof what the action might be, for example, if a misconfiguration of theconnection is indicated.

In any of the disclosed embodiments, the distal pressure sensor may belocated within a peritoneal cycler machine or on the tubing set leadingto the patient and close to the machine. The distal pressure sensor maybe located near the patient and on the tubing set or within a peritonealcatheter. It may also be separated from the tubing set and positionedwithin the peritoneum. In such an embodiment, the pressure sensor linesmay be attached to the tubing set. For example, metallized surface ofthe tubing or a co-extrusion (wire insulation and tubing beingcoextruded) may be attached to the tube at points therealong.

In any of the disclosed embodiments, an osmotic agent, concentrated ordilute, or a peritoneal dialysis solution or concentrate thereofcontaining glucose or any other precursor of a dialysis solution maycontain glucose that has not been treated with heat. In any of theseembodiments, the glucose concentrate or solution or dialysis solution orprecursor containing glucose may be sterile filtered as it is stored ina sterile container without using heat sterilization at all. This avoidsheat sterilization byproducts of glucose that are toxic. In a methodembodiment, a sterile package including a bag has an inline sterilizingfilter (e.g., 0.1 micron porosity sterilizing filter) at a filling portthereof. The port may be elongate and have a nonreopenable closure onthe filling port. Another port, sealed at the time of filling, may beused to access the contents. Before filling, the sealed container issterilized by gamma sterilization or heat sterilization. Then theglucose solution is pumped into the container through the inline sterilefilter and the nonreopenable closure feature is closed. Thenonreopenable feature can be just a weldable tube neck which is sealedby thermoplastic welding. Other sealing devices may be used.

Below, and in the claims, flow path selection actuators may include theactive parts of automatic valves, for example, the valve actuatorsdisclosed in the foregoing embodiments such as tube clamps, lineardrives that close membrane valves (e.g., FIGS. 8B and 8C).

FIG. 20 shows a sequential solution mixing system 1100 that employsrepeatable volumetric displacement to provide predicted component ratiosof constituent fluids. FIG. 21 shows a method for mixing a solution,such as a medicament, which may be used with any suitable systemincluding the system of FIG. 20 and the foregoing PD dialysate mixingsystems described elsewhere in the present specification. The system1100 has a pump/flow selector device 1110 that connects each of thesources 1102, 1104, 1106, and 1108 to a batch container 1112 and furtherpumps fluid from each of the sources 1102, 1104, 1106, and 1108 to thebatch container consecutively using a pump 1118. Although four sourcesare shown, there can be any number including fewer or more. Thesesources can represent containers or inline production plants or anyother type of fluid source. The pump/flow selector device 1110 may beconfigured as described with reference to FIG. 8D or 10, for example,but may be any type of arrangement employing a pump and a flow switchingmechanism.

A sterile filter or other type of filter may be used in one or all ofthe constituent flow paths. In an embodiment, the flow selector/pump1110 and source fluids 1104, 1106, and 1108 (which may vary in number ofcomponents; i.e., more or fewer than illustrated) and the batchcontainer form a single sealed disposable unit whose only point of entryis through a connector to the source 1102. In an embodiment, the source1102 is a source of diluent, such as water and the other sources areprovided in sealed containers as concentrates. As a result of thisconfiguration, the risk of contamination from the source 1102 or fromthe single connector (not shown but connecting the source 1102 and thefilter) used for connecting to the source 1102 to the filter is greatlyreduced. In the case of a medical apparatus, the risk of bacterialcontamination is reduced using a sterile filter such as a membranefilter with a bacteria-blocking or pyrogen blocking pore size, forexample, 0.1 or 0.2 micron.

The pump 1118 is of a type which, once set up, is repeatable, but maynot accurate in terms of how much volume is displaced by it for a givenmechanical displacement of the pump. For example, if the pump 1118 is ofa peristaltic type, the number of rotations will correspond to a fixedvolume of fluid being transported thereacross, but this will varydepending on the particular tubing attached to the peristaltic pump. Themechanical properties of the tubing material, variations in wallthickness of the tubing, how the tubing is placed between the pump rotorand race, etc. may affect the volume displaced per rotation of therotor. These configuration parameters vary when the tubing is replacedas is typical in medical applications where tubing is sterilized anddisposable. As a result, the pumping process may be variable between theestablishment of one configuration and the next. For example a firstconfiguration may be established when a particular tubing set isinstalled and then a second configuration established when anothertubing set is installed. Configurations that may affect the relationshipbetween the controlled output (displaced volume) and the regulated input(cycles of the pump) may include one or more of:

1. Replacement of components;

2. An idle time between successive mixing operations;

3. Cleansing or sterilization of the components;

4. Temperature of the components or change in temperature;

5. Lapse of a period of time of continuous or discontinuous use; and/or

6. Change in fluids being pumped.

Despite the variability that can attend configuration changes, thepumping rate may be consistent, within a single configuration, such thatif a first fluid is pumped, followed by a second fluid, the quantity ofeach fluid may be proportional to the number of cycles of the pump. Fora peristaltic pump, each cycle corresponds to a rotation of the rotor.For a centrifugal pump it may correspond to a time interval at apredetermined speed. For a magnetohydrodynamic pump, it may correspondto power level over the pumping interval. In an exemplary embodiment,the peristaltic pump has been determined to exhibit repeatable volumedisplacement to pump rotor displacement within a single configuration.

As discussed above, mixing target ratios of components to form a batchof fluid need not rely on knowledge of actual flow rate, as long astarget ratios can be established in the mixture. Thus, calibration isnot required for mixing to target concentration ratios. However, as inembodiments herein, the combining and mixing device also functions as aperitoneal cycler. It is desirable to be able to convey predefinedquantities of fluid into a patient for treatment purposes and to measurethe amount of fluid withdrawn for purposes of measuring theultrafiltration rate and to avoid overfilling the peritoneum. Thus, thecalibration of the pump may be used by the controller to determine thenet quantity of fluid transferred to the patient and the net quantitydrawn from the patient.

Accurate proportioning of components to achieve a target ratio of theconstituents may be augmented by compensation factors that may bedetermined in advance and stored in the controller. These compensationfactors may compensate for various factors that influence the ratio ofpump cycles to volume displaced different for different fluids flowingin somewhat different flow paths. In the above-described scheme, fluidis conveyed from each of several flow sources, for example, componentconcentrate containers and a source of water. Although the same pump isused to pump each component, the paths are somewhat different. Similarlythe flow path of prepared dialysate from the batch container to thepatient differs from the flow path of spent dialysate from the patientto the drain. Further the properties of the fluid may be different.Compensation factors may be stored in the controller and used to allowtarget ratios of the different dialysate components to be achieved inthe final dialysate batch. For example, suppose the flow path of glucoseconcentrate to the batch container is determined to permit a lowervolume of fluid to be transported therethrough for a given number ofpump cycles than the flow path of electrolyte to the batch container. Inthat case, then a higher compensation factor may be stored for theglucose path than for the electrolyte path. The compensation factor maybe used to determine the number of pump cycles so that a larger numberof pump cycles per unit volume is used, per unit required, to transferglucose than for transferring electrolyte per unit volume. Although theabsolute volume transferred need not be known with accuracy, the use ofthe compensation factors may preserve the relative ratio of thetransferred glucose concentrate and electrolyte concentrate. Note thatthe compensation factors may be stored as ratios between fluids so thatif the mixing involves N fluids, only N−1 factors need to be stored.

Such compensation factors may be generated by experiment in thelaboratory using a variety of tubing sets. Compensation factors may begenerated similarly for purposes of controlling the total transferredvolume of fresh dialysate to the patient as well as the totaltransferred volume of spent dialysate from the patient. In this case, itis desired to measure the transferred volume. So the compensationfactors help to establish the ratio of pump cycles to volume transferredin absolute terms. A compensation factor for measuring the flow of spentdialysate from patient to drain may account for assumed properties ofspent dialysate as well as the particular flow path. For determining thevolume of dialysate transferred to and from a patient, a compensationfactor may be determined in the laboratory by experiment to allow thevolume transferred to be predicted from the pump rate given acalibration factor from a calibration procedure which compensates forvariability of the configuration and the properties of the fluid. Thus,a calibration may be performed as described with reference to FIG. 22Aand this data may be combined with an a priori compensation factor whichaccounts for the different flow path and properties in transferringfluid from the patient and to the patient. The calibration factorapplies to both spent and fresh dialysate transfer and the compensationfactor is respective of each. The calibration factor adjusts fordifferences in configuration attending changes and adjustments to theequipment and the compensation factors account for differences due toflow path and fluid properties. The combination of these may bemultiplied by the pump rate to yield flow rate or pump cycles to yieldtransferred volume.

Note that the calibration data may be stored in any type of data store.Calibration sequences as discussed above may be repeated to generate atable of compensation factors in which multiple conditions aregenerated. For example, temperature or upstream and downstream pressuresmay be varied to create a table of compensation factors for a variety ofconditions where each compensation factor is selected based on the onecombination of conditions that exist for which a flow rate is to becalculated. The prediction of actual transferred volume may be used toaugment the ratiometric proportioning discussed above and elsewhereherein. In an embodiment, the volume as predicted by numericalcompensation is used to determine the number of cycles of the pump whilethe pump cycle rates for each component are matched as discussed.

Since for admixing component fluids consistent proportions are requiredbut absolute quantities are less so, calibration may be unnecessary, forembodiments, for the combining of the components of a mixture, such asperitoneal dialysate. But for treatment, it is necessary to at leastquantify the difference between fluid taken from the patient and fluiddelivered to the patient because the difference represents the net fluidremoval, which is a treatment function of peritoneal dialysis. Tosupport the measurement of net fluid removal, calibration of the pump(which includes the pump tube segment in a peristaltic pump) may be doneeach time a configuration change occurs. Calibration may be augmented,as discussed below, by compensation factors that account for differencesin physical flow path characteristics and fluid properties (e.g., thedifferences between the viscosity of spent vs. fresh dialysate). Thecompensation factors may be obtained by experiment and stored in acontroller and applied with respect to the respective flowconfiguration. Compensation factors may also be folded into pump cycleto fluid fraction ratios used for admixing components to form a batch.These compensation factors can be lumped together with the requiredratios for respective prescriptions in a lookup table or applied in aformula.

For admixing, a formula approach is to store a compensation factor foreach flow path. The compensation factor for a given component fluid pathmay be multiplied by the nominal number pump cycles per unit volume forthe pump as and used to control the transfer of the given component tothe batch according to the prescription. Alternatively, a lookup tablemay be used to store a set of predefined prescriptions with pump cyclesfor each component for each prescription. The stored pump cycles canincorporate the compensation for the differences in each flow path.

The mixing system 1100 may take advantage of repeatability to createaccurate constituent ratios in the batch container by employing a singleconfiguration to pump all of the component fluids 1102 to 1108 into thebatch container without changing the configuration and using the samepump 1118 (which in the case of a peristaltic pump, may include a pumptube). After, or during, the pumping of component fluids, the pump mayalso be used for mixing fluids as has been described above.

It has been determined that not only does the configuration affect therepeatability of a pumping configuration, such as a peristaltic pump,but maintaining the pumping rate across the different component fluidsmay make the ratio more consistent. Thus, referring now to FIG. 21, inan embodiment, at S122 component fluid 1102 is first pumped at apredefined rate Q that is held constant for a predetermined number ofcycles of the pump 1118. Then at S124 component fluid 1104 is pumped atthe predefined rate Q which is held constant for a predetermined numberof cycles of the pump 1118. Then at S126 component fluid 1106 is pumpedat the predefined rate Q which is held constant for a predeterminednumber of cycles of the pump 1118. Then at S128 component fluid 1108 ispumped at the predefined rate Q which is held constant for apredetermined number of cycles of the pump 1118. At S130, the componentsmay be mixed at a first rate which is switched to a second rate at S132and the rate switching repeated until a mixing interval is elapsed. Themixing may be done by pumping the batch container 1112 contents througha loop out of and back into the batch container 1112. One of these rates(first S130 and second S132) may be lower than the other rate ofpumping. In another embodiment, one of these rates (first S130 andsecond S132) may be zero rate of pumping which allows the liquids tosettle. In another embodiment, the flow is periodically reversed so thatthe first rate is the reverse and/or different magnitude relative to thefirst. It has been determined that mixing in this manner, that is,varying the rate of mixing, provides more effective mixing in a givenperiod of time than running continuously. At S134, after a predeterminednumber of cycles, or a period of time, the mixing ends and the batch ismade available for use.

Alternative embodiments include mixing systems of any sort, for example,aqueous concentrate mixing systems. Mixing may also be promoted bypulsing the pump. The mixing and proportioning embodiments describedherein may be applied to the embodiments of FIGS. 6A13, 17A-17H,17J-17N, and 17P-17T, and 19 as well as other configurations.

For ensuring accurate proportioning despite variability that resultsfrom configuration changes, it is also possible to compensate forchanges in pumping rate. For example, an empirical function thatestimates actual flow rate for a given flow path for a given pump cyclerate may be stored. For example, the table may store function parametersin columns or rows for pump rotor RPM and complementary rows or columnsfor each flow path. Thus, rate Q1 may be used for component fluid 1 andQ2 for component fluid 2. If the target ratio of Q1 to Q2 in the mixtureis 2:1, then the pump may be run for 2 N cycles while pumping fluid 1and N cycles for pumping fluid 2. This is the general scheme discussedabove. But with a compensation factor, one of the fluids may be pumpedat a faster rate and the number of pump cycles modified by a factor,which factor may be empirically derived and stored in a table or list.In an example, the compensation factor may result in the fluid that ispumped faster being pumped for slightly more pumping cycles than theother fluid. In a method, multiple configurations are tested to providethe compensation factor. The compensation factor may also be respectiveto each flow path as well. For example, a first flow path betweenconcentrate A and batch container may have one or a set (each respectiveto a certain flow or pump cycle rate) and a first flow path betweenwater and the batch container may have another, or another set (eachrespective to a certain flow or pump cycle rate).

FIG. 22A shows a system for mixing component fluids to form a batch andwhich includes a description of features for calibrating one or morepumps. FIG. 22A shows a sequential solution mixing system 1101 thatemploys repeatable component flow rate of component fluids to achievetarget ratios thereof without measuring the specific flow rate ortransferred volume. The system 1101 features now described may be usedwith any of the systems or methods described herein. The pump/flowselector device 1110 connects each of the sources 1102, 1104, 1106, and1108 to a batch container 1112 and further pumps fluid from each of thesources 1102, 1104, 1106, and 1108 to the batch container consecutivelyusing a pump 1118. The pump/flow selector device 1110 may be configuredas described with reference to FIG. 8D or 10, for example, but may beany type of arrangement employing a pump and a flow switching mechanism.The pump/flow selector device 1110 may also connect each or some of thesources 1102, 1104, 1106, and 1108 to a drain line 1151, to a consumerline 1153 (e.g., a patient fill/drain line for peritoneal dialysis)which may be used to draw fluid from the batch or from any of thesources 1102, 1104, 1006 or 1108, with the pump 1118 providing themotive force and flow rate regulation for any of the selected transfers.The pump/flow selector 1110 provides the switching required to effect aselected transfer.

A controller 1132 is connected to the pump/flow selector 1110 to controlthe pump/flow selector 1110. The controller may be configured accordingto any of the disclosed embodiments and programmed according to any ofthe disclosed or claimed methods. The controller may be configured torun the pump to flow fluid from the source 1102 to and through the drainline 1151. The controller may be further configured to momentarilyconnect the source 1104 to the drain line 1151 and pump fluidtherethrough. The properties of the fluids from the sources 1102 and1104 are different and detectable by first and second detector 1155 and1150. The controller may measure the time delay between detection by thefirst detector 1155 and detection by the second detector 1150. Withknowledge of the volume between the first and second detectors, the timedelay, it is possible to derive the flow rate. This may be doneautomatically using the same components as used for combining and mixingcomponents for a batch by the addition of the required propertydetectors.

In embodiments, the property detectors are air sensors and air (bubbles)are injected in the fluid line. A small amount of air can be readilydetected by air detectors that are standard in blood treatment systems.Conductivity, both contact type and inductive, can also be detectedreadily.

In embodiments, the dual sensors are used for redundant propertymeasurement to confirm the quality of a mixed dialysate batch beforeuse. The use of redundant sensors is discussed above with reference toredundant sensors 984 and 985 in FIG. 9 and elsewhere. In embodiments,the redundant sensors are spaced apart by a flow channel with aprecisely defined and known volume such that they can be used asdescribed for flow rate measurement and calibration. In any of theembodiments in which redundant sensors are used, the controller may beconfigured to detect not only the property the sensors are adapted tomeasure, but also to verify the measurement by comparing the sensorsignals for agreement. In embodiments, a pair of conductivity sensorsare provided in the drain line as disclosed in various embodimentsherein. After mixing a batch of dialysate, a sample of the mixed fluidis pumped to the drain so that its conductivity can be measured by thepair of conductivity sensors. The measured conductivity of each sensoris compared with a predefined allowable range stored as data by thecontroller. If the measured conductivity indicated by either sensorfalls outside the allowed range, an output is generated on the userinterface to indicate a fault condition. Alternatively, the measuredconductivities of the two conductivity sensors are averaged and comparedto the predefined range and if the average is outside the range, thenthe fault indication is generated. The predefine range may be one ofseveral, each of which correspond to a respective prescription. Thecontroller may be further configured to compare the conductivitymeasurements to each other and generate a fault signal if the differencebetween the measurements exceeds a predefined disagreement threshold,which threshold may be stored by the controller. The disagreementthreshold may be stored as a percentage or an absolute quantity andmultiple values may be stored, each for a respective prescription orrange of prescriptions. In addition to outputting an indication of afault on a user interface, the fault signal may be used to halt thepump, operate the valves to prevent use of the dialysate, and othermeasures.

In an alternative embodiment, a single detector may be used and theelapsed time the time from the initial flow from source 1104 into thepumping line is measured by the controller. As in the previousembodiment, the time delay from injection of fluid from source 1104 todetection may be combined with the predetermined volume of the fluidcircuit between the point of connection of the source 1104 and thedetector 1150 to determine the rate of flow.

Using the time delay data and the flow volume data, flow rate can bederived and a correlation between pump cycling rate and flow rate can beestablished and recorded in the controller.

Another way to provide accurate proportioning in the batch admixture isto mitigate the effect of changes in pumping speed, rather than keep thepumping rate constant as discussed with reference to FIG. 20. In anembodiment, components of the batch solution are pumped at differentrates. When the valves are switched from a first fluid to a second, acertain initial portion of the second fluid is conveyed to the drainbefore the valves are switched to flow the second fluid to the batchcontainer. This may eliminate any initial or transient, properties whichaffect the ratio of displaced volume to pump cycles that cannot beaccounted for by a compensation factor. The controller may beconfigured, thus, to operate the valves so as to connect a new source offluid momentarily to the drain and then to the batch container. Afterswitching the flow path to the container, the controller begins tocumulate transferred volume to convey a selected amount of the newsource fluid to the batch container. FIG. 22B illustrates this procedurefor the component fluids of the configuration of FIG. 22A. At S202,fluid is pumped from source 1102 at a first rate Q1 to the batchcontainer 1112. At S204, the pump/flow selector 1110 briefly connectsthe source 1104 to a secondary outlet, for example, the drain 1153 andthen connects the source 1104 to the batch container 1112 at a rate Q2which may be different from rate Q1. At S206, fluid is pumped fromsource 1104 at a second rate Q2 to the batch container 1112. At S208,the pump/flow selector 1110 briefly connects the source 1106 to asecondary outlet, for example, the drain 1153 and then connects thesource 1106 to the batch container 1112 at a rate Q3 which may bedifferent from rate Q1, Q2, or both. At S210, fluid is pumped fromsource 1106 at a third rate Q3 to the batch container 1112. At S212, thepump/flow selector 1110 briefly connects the source 1108 to a secondaryoutlet, for example, the drain 1153 and then connects the source 1108 tothe batch container 1112 at a rate Q4 which may be different from rateQ1, Q2, Q3, or any of them. At S214, fluid is pumped at rate Q4 untilthe required amount is displaced and at steps S130 and S132, theresulting batch is mixed as described with reference to FIG. 21.

Note that although embodiments in FIGS. 20 through 22B contemplate fourcomponent fluids, two, three and higher numbers of fluids can be used.The embodiments of FIGS. 20 through 22B illustrate features that may beapplied to any of the embodiments described herein, including of thoseof FIG. 6A et seq.

In embodiments described, for example the detector 1150 (1155), aconductivity cell may be used to measure fluid conductivity. This may bea contact type or non-contact type conductivity sensor or detector.However, other types of property sensors may be used. The fluid used forlabeling may be pure water, air, saline. Any combination of fluids thatmay produce an edge to act as a position label in a fluid stream may beused. Also, the label may be just an interface between two fluids (orany detectable fluid property perturbation such as bolus of bubbles, atemperature change, etc.) so that a single switchover between one fluid(without reversion to the original fluid) may suffice to act as a traveltime indicator. The source of air used for labeling may be any source ofair. For example, it may be the same source as used for testing offilter integrity so that a single filtered source of air may be used fortwo purposes. For example, see the bubble point test used for filterintegrity test as described with reference to FIG. 9 and elsewhereherein.

The above-described technique for pump calibration may be employed inthe embodiment of FIG. 10 in which a PD cycler is used with prepared PDdialysate. In this case only a single fluid may be available. Toovercome this problem, the fluid circuit apart from the prepareddialysate, may be pre-filled with sterile pure water which is displacedduring priming with the dialysate. The interface between the pure waterand the dialysate may thus be used to label the fluid flowing in a path.This may be done multiple times, for several calibration runs, with apure water slug injected from each prefilled line (lines 1010, 1011, and1012) while dialysate is pumped through a different line from adifferent source 1002 and initially, the interface between a source andthe prefilled line can be serve as a label for transit time capture.

The above calibration procedures may be implemented so that they areperformed once for each batch of PD fluid. Alternatively, they may beperformed once each time a disposable circuit is attached to thetreatment/preparation system. This may allow for differences in thedisposable configuration such as material variability and assemblyvariability to be compensated adequately. Calibration may be performedin response to the lapse of a certain amount of time. In addition to theabove, other calibration procedures may be performed, such asgravimetric calibration where a transferred fluid is weighed, flowsensor (volumetric or velocity sensing) calibration, etc.

Referring now to FIG. 23A, a system for mixing component fluids to forma batch has a permanent pump/flow selector device 1210 which isconnected to disposable components, avoiding the need for a disposablemanifold component as described in other embodiments herein. Thepump/flow selector device 1210 further has a heater 1244 with which itmay sterilize the internal fluid circuits, sensors, and pump. Thepump/flow selector device 1210 may provide a sequential solution mixingsystem 1201. The use of a permanent pump/flow selector device may permitthe use of a precision positive displacement pump 1218 for example, andrigid flow channels. In the system 1201 the pump/flow selector device1210 connects each of the sources 1202, 1204, 1206, and 1208 to a batchcontainer 1212 and further pumps fluid from each of the sources 1202,1204, 1206, and 1208 to the batch container consecutively using the pump1318. Although four sources are shown, there can be any number includingfewer or more. These sources can represent containers or inlineproduction plants or any other type of fluid source. The pump/flowselector device 1210 may be configured to function as described withreference to FIG. 8D or 10, for example, but may be any type ofarrangement employing a pump and a flow switching mechanism but with thedifference that the flow selection and pumping are provided by permanentcomponents therein.

The pump/flow selector device 1210 may also connect each or some of thesources 1202, 1204, 1206, and 1208 to a drain line 1251, to a consumerline 1253 which may be used to draw fluid from the batch or from any ofthe sources 1202, 1204, 1206 or 1208 the pump 1218 providing the motiveforce and quantification for any of the transfers and the flow selectorportion of the pump/flow selector 1210 providing the switching requiredto effect a selectable transfer. The configuration of the flow selectorportion of pump/flow selector 1210 may be configured in various ways forinterconnecting the sources and sinks illustrated.

The sources 1202, 1204, 1206 or 1208, which may include a water source1202, and batch container 1212, may be configured as part of adisposable unit 1205. Alternatively water may be provided through thepermanent pump/flow selector 1210 portion via a water line 1207 from awater purification plant (not shown but which may be as described withreference to other embodiments disclosed herein). The disposable unit1205 may be provided with a set of connectors 1266A (only one connectoris indicated by a lead line but the remaining are self-evident) forconnection to the pump/flow selector 1210 plant. The disposable unit1205 may include a support that inter-attaches all the sources and thebatch container as well as the patient line 1253, or may be separatecomponents. In an embodiment, the support interconnects all theconnectors 1266A to allow the attachment of all the connectors in asingle manual operation. The pump/flow selector 1210 has a set ofconnectors 1266B, one for each of the connectors 1266A. The pump/flowselector 1210 may also provide purified water through a water line 1207.In an embodiment, the pump/flow selector 1210 includes a waterpurification plant which may be as described according any of thedisclosed embodiments. It may also include the drain line 1251 andredundant conductivity cells 1255 and 1250 as well as a connection to aplumbing drain. The redundant conductivity cells 1255 and 1250 may beused for calibration as discussed above.

A return header 1240 may allow the pump/flow selector 1210 to circulatesterilizing water or fluid through all of the internal fluid circuitryas well as for sterilizing the connectors. The return header 1240 hasrespective connectors 1266C for each connector 1266B of the pump/flowselector 1210. The return header 1240 may be simply a single flow plenumconnecting all the connectors 1266B. The pump/flow selector 1210 may beconfigured to vary the flow paths through the return header 1240 toprovide for full sterilization of the connectors and the pump/flowselector 1210 internal plumbing. The details of the internal flowcircuit of pump/flow selector 1210 may be functionally as described withreference to other embodiments. As depicted in FIG. 23B, the pump/flowselector 1210 may include permanent valves 1272 and internal permanentflow lines 1274 interconnected to provide the functionality describedwith reference to other embodiments. In a sterilizing operation, thevalves 1272, heater 1244, and pump 1218 may be sequenced to circulatehot fluid through all the components and the return header 1240. Thereturn header 1240 may be removed and the connections to the disposable1205 made. Then the treatment fluid preparation may be performed asdescribed with reference to the other embodiments by sequentiallyoperating the valves 1272 and pump 1218 under control of the controller1232. The controller 1132 is connected to the pump/flow selector 1210 tocontrol the selected transfers. The controller may be configuredaccording to any of the disclosed embodiments and programmed accordingto any of the disclosed or claimed methods.

Referring to FIG. 23C, the return header 1240 may be configured as amovable attachment to the pump/flow selector 1210 component. In FIG.23C, the return header is shown at 1240A in a first position forsterilization and in a second position 1240B to allow access toconnectors 1266B to be accessed by the disposable 1205 connectors 1266A.In the embodiment, the return header 1240 is illustrated as a pivotingelement, but it can also be separate or movable in some other mode suchas sliding displacement or tethered to the pump/flow selector 1210component by a flexible leash. The movement may be implemented by amotor (not shown) under control of the controller 1232.

In any of the disclosed embodiments in which the pump is calibrated, thecalibration data derived from the calibration may be used by thecontroller to:

Calculate a volume of fluid transferred to the patient;

Calculate a volume of fluid transferred from the patient;

Calculate a difference between a volume of fluid transferred to thepatient and a volume of fluid transferred from the patient;

Determine an amount of fluid being transferred to a patient to comparethe amount with a predetermined amount and to regulate the pump so thatthe amount being transferred does not exceed the predetermined amount;and

Calculate a difference between a volume of fluid transferred to thepatient and a volume of fluid transferred from the patient and output anindication if the net transfer is outside a predefined range, the outputmay be applied to a user interface, a data store such as a treatment logor communicated to an external terminal.

Calculated data may be stored or communicated for storage in a treatmentlog or displayed on a user interface.

In any of the disclosed embodiments, instead of recirculating fluid inthe batch container, or in addition thereto, fluid can be mixed usingany of a variety of other devices and methods. These include:

-   -   A batch container support that oscillates the batch container;    -   A magnetic stirrer inside the batch container that is moved in        response to a moving magnetic field generated by the support,        which may done by a mechanical device or armature;    -   A batch container support or element adjacent to the batch        container that vibrates, including ultrasonic vibration;    -   A magnetohydrodynamic induction mixer;    -   A flexible tube through which fluid exits into the batch        container may augment the recirculation mixing described as the        dip tube whips around inside the batch container due to the        reaction to the momentum of fluid ejected from an end thereof;        and    -   Water may be prefilled in the batch container and concentrate        flowed slowly into the container at a top thereof to induce a        circulation owing to the higher density of the concentrate.

While the present invention has been described in conjunction with anumber of embodiments, the invention is not to be limited to thedescription of the embodiments contained herein, but rather is definedby the claims appended hereto and their equivalents. It is furtherevident that many alternatives, modifications, and variations would beor are apparent to those of ordinary skill in the applicable arts.Accordingly, Applicant intends to embrace all such alternatives,modifications, equivalents, and variations that are within the spiritand scope of this invention.

According to embodiments, the disclosed subject matter includes (A) afluid flow system for peritoneal dialysis with a pump that has an inletand an outlet, the pump being configured to pump fluid from the inlet tothe outlet. The system has first flow paths with control valvesselectably connectable to the pump inlet, where the first flow paths areconnected respectively to respective sources of at least one concentrateand water, and to a dialysis fluid batch container. The system hassecond flow paths with control valves selectably connectable to the pumpoutlet, the second flow paths being connected respectively to thedialysis fluid batch container, a patient access line, and a drain line.The drain line has first and second conductivity sensors connected inseries in the drain line. A controller is connected to the pump, thecontrol valves, and the first and second conductivity sensors and isconfigured to operate the pump, connect the first and second flow pathsselectably, and measure conductivity of fluid in the drain line. Thecontroller is configured to operate the pump and the control valves tocreate a fluid interface between first and second fluids and convey theinterface to the drain line and further to store time data representinga time interval between a time the interface crosses the firstconductivity sensor and the time the interface crosses the secondconductivity sensor. This effectively forms the basis of a pumpcalibration. The time data can be used to regulate the pump cycle speed(cycle speed corresponding to the pump RPM for a peristaltic pump) so asto maintain a target flow rate. In embodiments, the target flow rate isused for balancing peritoneal fluid to and from the patient so that netfluid loss or gain can be calculated. The net fluid gain or loss, inembodiments, is calculated by the controller. The calibration adjustedflow also allows a target volume to administered to a patient duringcycler-assisted peritoneal dialysis treatment.

In variations of embodiment (A), the controller may be configured tocontrol the quantity of dialysate delivered by limiting the total volumetransferred to a predetermined amount, or halt if a predeterminedpressure is measured at the distal end of the fill/drain or fill line,whichever occurs sooner during a filling operation. The controller maybe configured to operate the pump and the control valves to flow the atleast one concentrate and water into the dialysis fluid batch container,to mix the at least one concentrate. Thus, the system may be a combinedone for preparing dialysate and performing cycler assisted peritonealdialysis. As part of the calibration procedure, the controller may beconfigured to operate the pump and the control valves to create a fluidinterface between first and second fluids and convey the interface tothe drain line and further to store time data representing a timeinterval between a time the interface crosses the first conductivitysensor and the time the interface crosses the second conductivitysensor. To support the cycler-assisted peritoneal dialysis treatment,the controller may further be configured to operate the pump and thecontrol valves to transfer fluid from the patient access to the drain.Further the controller may be configured to operate the pump and thecontrol valves to transfer fluid from the dialysis fluid batch containerto the patient access and further configured to operate the pump and thecontrol valves to transfer fluid from the patient access to the drainresponsively to the time data.

In further variations of embodiment (A), the controller may be furtherconfigured to operate the pump responsively to the time data and thecontrol valves to transfer fluid from the dialysis fluid batch containerto the patient access and further configured to operate the pump and thecontrol valves to transfer fluid from the patient access to the drain.The controller may be further configured to operate the pump and thecontrol valves to transfer fluid from the dialysis fluid batch containerto the patient access and further configured to operate the pump and thecontrol valves to transfer fluid from the patient access to the drain.The controller may be further configured to calculate net fluid transferdata responsive to a difference in the volume of transferred fluid fromthe dialysis fluid batch container to the patient and the volume oftransferred fluid from the patient access. The net fluid transfer datamay be calculated responsively to the time data and to store the netfluid transfer data in a data store. The controller may be furtherconfigured to communicate the net fluid transfer data as an outputsignal, to display it on a user interface, store it in a memory, and/oradd it to a treatment log stored on a non-volatile data store. In any ofthese embodiments, the pump may be peristaltic pump.

According to embodiments, the disclosed subject matter includes (B) aperitoneal dialysis system with a fluid batch preparation componentconfigured to prepare a batch of dialysate and a cycler componentconfigured to perform cycler-assisted peritoneal dialysis treatment. Thesystem includes a controller configured to operate the batch preparationand cycler components. It also includes a peristaltic pump shared by thecycler component and the fluid batch preparation components, thecontroller being configured to calibrate the pump to generatecalibration data. The controller uses the calibration data to do atleast one of the following in any combination according to variations ofembodiment (B):

-   -   Calculate a volume of fluid transferred to a patient;    -   Calculate a volume of fluid transferred from the patient;    -   Calculate a difference between a volume of fluid transferred to        the patient and a volume of fluid transferred from the patient;    -   Determine an amount of fluid being transferred to a patient to        compare the amount with a predetermined amount and to regulate        the pump so that the amount being transferred does not exceed        the predetermined amount; and    -   Calculate a difference between a volume of fluid transferred to        the patient and a volume of fluid transferred from the patient        and output an indication if the net transfer is outside a        predefined range, in further variations of embodiment (B), the        output may be applied to a user interface, a data store such as        a treatment log or communicated to an external terminal.

In variations of embodiment (B), the cycler and fluid batch preparationcomponents may share a drain line with first and second conductivitysensors. The controller may be configured to compare a conductivity of abatch of fluid, prepared by the fluid batch preparation component,indicated by the first and second conductivity sensors, to a predefinedrange and output a result of the comparing. The controller may beconfigured to compare conductivities indicated by each of the first andsecond conductivity sensors to each other and output a result of thecomparing. The first and second conductivity sensors may be arranged inseries along the drain line and the controller is configured tocalibrate the pump at least in part by generating a conductivityperturbation in a flow through the drain line and measuring a timebetween successive detections of the perturbation by the first andsecond conductivity sensors.

In further variations of embodiment (B), the controller may beconfigured to generate the conductivity perturbation by flowing a firstand second fluids in the drain line, wherein one of the fluids is water,wherein the first and second fluids have different conductivities. Thecontroller may be configured to generate the conductivity perturbationby flowing a portion of a batch of dialysate and purified water in thedrain line, in succession. The controller may be configured to generatethe conductivity perturbation by flowing water and a portion of a batchof dialysate in the drain line, in succession. The fluid batchpreparation module may include flow path selection actuators that areconfigured to connect a batch container with a water source and one ormore concentrate containers.

In further variations of embodiment (B), the cycler and fluid batchpreparation components share a drain line connected to a drain. Thecontroller may be configured to control the flow path selectionactuators and the pump to transfer fluid from a concentrate containerand a water source at a single pumping rate. The controller may beconfigured to control the flow path selection actuators and the pumpsuch that between a time of pumping water and a time of pumpingconcentrate, a bolus of the concentrate is transferred to the drain andthen a quantity of the concentrate is transferred to the batchcontainer.

According to embodiments, (C) the disclosed subject matter includes aperitoneal dialysis system with a fluid batch preparation componentconfigured to prepare a batch of dialysate. The system includes a cyclercomponent configured to perform cycler-assisted peritoneal dialysistreatment and a controller configured to operate the batch preparationand cycler components. The system also includes a peristaltic pumpshared by the cycler component and the fluid batch preparationcomponents. The cycler and fluid batch preparation components share adrain line connected to a drain and the controller is configured tocontrol the flow path selection actuators and the pump to transfer fluidfrom a concentrate container and a water source to a batch containerthat holds the batch of dialysate. The controller is further configuredto do at least one of the following in any combination according tovarious embodiments based on embodiment (C):

Pumping fluid at a same pumping rate when a first flow path fortransferring water to the batch container as when pumping concentrate tothe batch container; or

Controlling the flow path selection actuators and the pump such thatbetween a pumping water and pumping concentrate, a bolus of theconcentrate or water is transferred to the drain effective to ensure aconstant relationship between pumping speed and flow rate during thetransfer of the concentrate or water to the batch container.

In further variations of embodiment (C), the controller may beconfigured to prepare a batch of fluid and then to performcycler-assisted peritoneal dialysis treatment with the batch of fluid.

According to embodiments, the disclosed subject matter includes (D) aperitoneal dialysis system with a fluid batch preparation componentconfigured to prepare a batch of dialysate. The system includes a cyclercomponent configured to perform cycler-assisted peritoneal dialysistreatment and a controller configured to operate the batch preparationand cycler components. The system further includes a peristaltic pumpshared by the cycler component and the fluid batch preparationcomponents. The cycler and fluid batch preparation components share adrain line connected to a drain. The controller is configured to controlthe flow path selection actuators and the pump to transfer fluid from aconcentrate container and a water source to a batch container that holdsthe batch of dialysate. The controller is further configured to flowwater to and from the batch container to mix the concentrate and waterafter they are transferred thereto, and when mixing, the controller willvary a rate of flow or periodically halt the flow that performs themixing during a mixing interval.

In variations of embodiment (D), the controller may be configured toprepare a batch of fluid and then to perform cycler-assisted peritonealdialysis treatment with the batch of fluid. The controller may vary therate of flow during the mixing. The controller may periodically halt therate of flow during mixing. The varying or halting of the mixing flowmakes the mixed batch mix better in a shorter period of time.

According to embodiments, the disclosed subject matter includes (E) amedical treatment device with a treatment machine configured to pump amedicament to a patient. The device has a flow line having a proximalend located at the treatment machine and a distal end attachable to apatient access. The device further has a distal pressure sensorpositioned to detect pressure in the flow line at the distal end. Thedistal pressure sensor includes an in-line pressure pod at the distalend with an air line running parallel to, and attached at points along,the flow line. The air line is connected at one end to the pressure podand at the other end to a pressure sensing assembly located at thetreatment machine. In a variation of embodiment (E), the flow line andair line form an integral plastic structure which may be formed bycoextrusion.

According to embodiments, the disclosed subject matter includes (F) amedical treatment device with a treatment machine configured to pump amedicament to a patient and a flow line with a proximal end located atthe treatment machine and a distal end attachable to a patient access.The line has proximal pressure sensor positioned to detect a pressure inthe flow line proximal end and a distal pressure sensor positioned todetect pressure in the flow line at the distal end. The distal pressuresensor includes an in-line pressure pod at the distal end with an airline running parallel to, and attached at points along, the flow line,the air line connected at one end to the pressure pod and at the otherend to a pressure sensing assembly located at the treatment machine. Ina variation of embodiment (F), flow line and air line form an integralplastic structure which may be formed by coextrusion. The treatmentmachine may be a peritoneal cycler.

According to embodiments, the disclosed subject matter includes (G) amedical treatment component with a pressure pod having a first chamberand a second chamber, the first chamber being separated from the secondby a diaphragm. The component has first and second tubes joined alongtheir length where the first tube has a lumen and is connected at afirst end thereof to the pressure pod such that the first tube lumen isin fluid communication with the first chamber. The second tube has alumen and is connected at a first end thereof to the pressure pod suchthat the second tube lumen is in fluid communication with the secondchamber. The first and second tubes have connectors at second endsthereof, which are opposite the first ends. The connectors arerespectively adapted for connection to a pressure transducer and aliquid medicament source.

In variation of embodiment (G), the first and second tubes may beintegrally attached along their length so that the first and secondtubes form an integral structure. The first and second tubes are may beprincipally a coextrusion with a uniform cross-sectional configurationalong a major portion of their lengths.

According to embodiments, the disclosed subject matter includes (H) amethod of performing a peritoneal dialysis treatment. The methodincludes connecting a disposable unit to a source of water, thedisposable unit including at least a first container holding a firststerile concentrate containing an osmotic agent, a second containerholding a second sterile concentrate containing electrolytes, an emptysterile mixing container, and a tubing set with a pre-attachedperitoneal fill/drain line. The method further includes receiving aprescription command by a controller, indicating at least the fillvolume and desired final concentration of the osmotic agent to be usedfor a current fill cycle under the treatment and using the controller,pumping quantities of concentrated osmotic agent, responsively to theprescription command and to achieve the desired final concentration,into the mixing container. The pumping includes using a single pump andpumping the water, the first sterile concentrate, and the second sterileconcentrate using a single pump speed to pump each of the fluids. Themethod further includes mixing the contents of the mixing container andfurther diluting or further adding concentrated osmotic agent to themixing container. The method includes flowing fluid from the mixingcontainer to a patient.

In a variation of embodiment (H), the method may further include, priorto the pumping a quantity of the concentrated osmotic agent,responsively to the prescription command, using the controller, pumpinga volume of water from the source of water into the mixing container.The method may include, after the mixing, detecting the concentration ofosmotic agent in the mixing container. The pumping may be such thatdifferent volumes of the first and second sterile concentrate areconveyed.

According to embodiments, the disclosed subject matter includes (I) amethod of preparing a treatment fluid. The method includes actuating aflow switch to connect a first fluid concentrate to a pump and flowingthe second fluid concentrate through the pump into a batch container ata first pumping rate. The method includes activating the flow switch toconnect a second fluid concentrate to the pump and flowing the secondfluid concentrate through the pump into the batch container at a secondpumping rate. The method includes activating the flow switch to connecta diluent fluid source to the pump and flowing the diluent fluid throughthe pump into the batch container at a third pumping rate. The methodincludes controlling a pumping rate of the pump to maintain constantpumping rates wherein the first, second, and third pumping rates areidentical and held constant during the pumping.

In a variation of embodiment (I), the flowing the first fluidconcentrate and the flowing the second fluid concentrate may be suchthat different overall volumes of the first and second fluidconcentrates are conveyed. The flowing the first fluid concentrate andthe flowing the diluent fluid may be such that different overall volumesof the first fluid concentrate and the diluent are conveyed. The flowingthe first fluid concentrate, flowing the first fluid concentrate, andthe flowing the diluent fluid may be such that the respective volumes ofthe first fluid concentrate, the second fluid concentrate, and thediluent conveyed to the batch container differ from each other. Themethod may include using the pump to mix fluid in the batch container.He method may include using the pump to mix fluid in the batch containerto convey mixed fluid from the batch container to a patient. The usingthe pump to mix fluid may include drawing fluid from a first connectorof the batch container and flowing fluid back into the batch containerthrough a second connector of the batch container. The using the pump tomix fluid may include periodically varying the rate of flow during amixing operation. The using the pump to mix fluid may includeperiodically halting the rate of flow during a mixing operation. Theusing the pump to mix fluid may include periodically reversing the flowduring a mixing operation. The method may include calibrating the pumpprior to generate at least one flow calibration parameter anddetermining a number of cycles of the pump responsively to the at leastone calibration parameter.

According to embodiments, the disclosed subject matter includes a fluidhandling system having connectors for the batch container and the firstand second source fluids and diluent sources, the system further havinga digital controller programmed to implement a method according to anyof the described methods.

According to embodiments, the disclosed subject matter includes a (J)disposable unit for peritoneal dialysis with a batch container and oneor more concentrate containers interconnected by a flow switch. The flowswitch is configured to be actuated by a predefined fluid managementsystem to define multiple flow paths therewithin. The flow switch has aport with either, a connector for a patient line or a patient line. Theconcentrate containers are prefilled with concentrate. A pump tubingsegment is connected to the flow switch and arranged to selectivelyinterconnect the port for flow therethrough.

In a variation of embodiment (J), the flow switch may be furtherconfigured to connect the batch container via two openings in the batchcontainer such that when the flow switch is suitably actuated by thepredefined fluid management system, fluid can flow between the twoopenings through the pump tubing segment. The batch container may be abag. The batch container and the one or more concentrate containers maybe bags. The unit may enclose an internal fluid handling volume that issealed and sterile.

According to embodiments, the disclosed subject matter includes a (K)disposable unit for peritoneal dialysis. A batch container and one ormore concentrate containers are interconnected by a flow switch. Theflow switch is configured to be actuated by a predefined fluidmanagement system to define multiple flow paths therewithin. The flowswitch has a port with a patient line and the concentrate containers areprefilled with concentrate. A pump tubing segment connects to the flowswitch and is arranged to selectively interconnect the port for flowtherethrough. The patient line has two collinear tubes attached alongtheir lengths and a pressure pod at a patient end thereof with one ofthe tubes being configured for connecting an air side of the pressurepod to a pressure transducer and the other end of the one of the tubesbeing connected to an air chamber of the pressure pod.

In a variation of embodiment (K), the flow switch may be furtherconfigured to connect the batch container via two openings in the batchcontainer such that when the flow switch is suitably actuated by thepredefined fluid management system, fluid can flow between the twoopenings through the pump tubing segment. The batch container may be abag. The batch container and the one or more concentrate containers maybe bags. The unit may enclose an internal fluid handling volume that issealed and sterile.

According to embodiments, the disclosed subject matter includes (L) adisposable kit for peritoneal dialysis. The kit includes a fluid circuitunit including a batch container and one or more concentrate containersinterconnected by a flow switch. The flow switch is configured to beactuated by a predefined fluid management system to define multiple flowpaths therewithin. The flow switch has a connector for a patient line.The concentrate containers are prefilled with concentrate. A pump tubingsegment connects to the flow switch and is arranged to selectivelyinterconnect the port for flow therethrough in either of oppositedirections. A patient line has two collinear tubes attached along theirlengths and a pressure pod at a patient end thereof with one of thetubes being configured for connecting an air side of the pressure pod toa pressure transducer and the other end of the one of the tubes beingconnected to an air chamber of the pressure pod.

In a variation of embodiment (L), the flow switch may be furtherconfigured to connect the batch container via two openings in the batchcontainer such that when the flow switch is suitably actuated by thepredefined fluid management system, fluid can flow between the twoopenings through the pump tubing segment. The batch container may be abag as may be the one or more concentrate containers. The unit mayenclose an internal fluid handling volume that is sealed and sterile.

According to embodiments, the disclosed subject matter includes (M) amethod of preparing a treatment fluid, that includes actuating a flowswitch to connect a first fluid concentrate to a pump and flowing thefirst fluid concentrate through the pump into a batch container at afirst pumping rate. The method includes activating the flow switch toconnect a second fluid concentrate to the pump and flowing the secondfluid concentrate through the pump into the batch container at a secondpumping rate. The method further includes activating the flow switch toconnect a diluent fluid source to the pump and flowing the diluent fluidthrough the pump into the batch container at a third pumping rate. Themethod includes, prior to the activating, performing a calibrationoperation to calibrate the pump and thereby generate at least onecalibration parameter. The activating operations include determiningwith a controller the pump responsively to the at least one calibrationparameter. The term flow switch, as describe elsewhere, is a fluidhandling system that can selectively convey fluid between selectedsources and destinations and the term activating refers to the use ofany mechanism that proves the selection of the alternative flow paths ofthe fluid handling system. A fluid handling system may have connectorsfor the batch container and the first and second source fluids anddiluent source, the system further having a digital controllerprogrammed to implement the foregoing methods.

According to embodiments, the disclosed subject matter includes (N) aself-calibrating medical treatment system with a fluid circuit thatincludes a pumping portion and a flow switching portion, the flowswitching portion being configured to connected between multiple fluidsources and a supply port for outputting fluid components or mixturesthereof. A controller is configured to control a pump in engagement withthe pumping portion and to control switching actuators interoperablewith the switching portion. The controller further has at least onefluid property detector configured to detect a change in fluid propertyat a point in the fluid circuit. The controller is configured tocalibrate a pumping operation embodied by an engagement of the pumpingportion and the pump by performing the following sequence:

-   -   1. controlling the pump and the switching portion to convey a        first fluid across the point;    -   2. controlling the pump and the switching portion to convey a        second fluid toward and across the point through a portion of        the fluid circuit having a predefined volume while measuring a        time interval until the second fluid reaches and is detected by        the at least one fluid property sensor;    -   3. generating a control parameter for mixing proportions of        fluids using the fluid circuit responsively to the time interval        and the predefined volume.        In a variation of embodiment (N), The controller may be        configured to calibrate the pumping operation when the fluid        circuit is replaced. The controlling the pump and the switching        portion to convey a second fluid toward and across the point        through the portion of the fluid circuit may include conveying a        bolus of the second fluid followed by the first fluid.

According to embodiments, the disclosed subject matter includes (O) amethod for supplying a patient for home peritoneal dialysis treatmentand for treatment during travel. The method includes supplyingcontainers of pure sterile water in a quantity for anticipated treatmentdays during travel. The method further includes supplying treatmentconcentrate in a quantity for anticipated treatment days during traveland non-travel treatment days.

According to embodiments, the disclosed subject matter includes (P) amethod of providing dialysate for continuous ambulatory peritonealdialysis (CAPD). The method includes using a device configured forpreparing a first batch of dialysate for at least one dialysis treatmentsession, the device having a mixed batch container into which fluids arepumped to prepare the first batch of dialysate for use in acycler-assisted peritoneal dialysis treatment. The method furtherincludes using the device to perform cycler-assisted peritoneal dialysistreatment in which a pumping portion of the device conveys dialysatefrom the first batch container to a patient's peritoneum and extractsthe first batch from the peritoneum, while measuring net fluid gain orloss between the fluid conveyed to the peritoneum and fluid extractedtherefrom. The method further includes using the device to prepare asecond batch of dialysate for CAPD, including connecting a CAPDcontainer to a predefined connector, filling the container from themixed batch container to the CAPD container.

In a variation of embodiment (P), the using the device to prepare asecond batch may be performed responsively to a controller signalindicating an end of a treatment cycle of which the using the device toperform cycler-assisted peritoneal dialysis treatment is a part. Themethod may include using a device configured for preparing a third batchof dialysate for a respective cycle of the cycler-assisted peritonealdialysis treatment.

According to embodiments, the disclosed subject matter includes (Q) asystem for implementing any of the methods defined above including afluid preparation and treatment device including concentrate dilutionand mixing components, an auxiliary port for attaching a container forreceiving dialysate therethrough and a controller programmed toimplement one or more cycler-assisted peritoneal dialysis treatmentcycles in which the controller controls the fluid preparation andtreatment device to prepare one or more batches of dialysate and fillsand drains a peritoneum one or more times. The controller is furtherprogrammed to prepare additional dialysate at the end of the one or morecycler-assisted peritoneal dialysis treatment cycles to fill theperitoneum and dispense additional dialysate through the auxiliary portfor use in CAPD. The dialysate flow from a batch container may be usedfor the cycler-assisted peritoneal dialysis treatment cycles to theauxiliary port to dispense the additional dialysate.

In any of the foregoing embodiments, methods and systems and devices maybe implemented using well-known digital systems. It will be appreciatedthat the modules, processes, systems, and sections described and/orsuggested herein can be implemented in hardware, hardware programmed bysoftware, software instruction stored on a non-transitory computerreadable medium or a combination of the above. For example, a method forcontrolling the disclosed systems can be implemented, for example, usinga processor configured to execute a sequence of programmed instructionsstored on a non-transitory computer readable medium. For example, theprocessor can include, but not be limited to, a personal computer orworkstation or other such computing system that includes a processor,microprocessor, microcontroller device, or is comprised of control logicincluding integrated circuits such as, for example, an ApplicationSpecific Integrated Circuit (ASIC). The instructions can be compiledfrom source code instructions provided in accordance with a programminglanguage such as Java, C++, C#.net or the like. The instructions canalso comprise code and data objects provided in accordance with, forexample, the Visual Basic™ language, LabVIEW, or another structured orobject-oriented programming language. The sequence of programmedinstructions and data associated therewith can be stored in anon-transitory computer-readable medium such as a computer memory orstorage device which may be any suitable memory apparatus, such as, butnot limited to read-only memory (ROM), programmable read-only memory(PROM), electrically erasable programmable read-only memory (EEPROM),random-access memory (RAM), flash memory, disk drive and the like.

As used herein and in the claims, the term cycler-assisted peritonealdialysis describes transferring fluid to the peritoneum of a living hostand transferring fluid from the peritoneum of the host after a period oftime.

Furthermore, the modules, processes, systems, and sections can beimplemented as a single processor or as a distributed processor.Further, it should be appreciated that the steps mentioned above may beperformed on a single or distributed processor (single and/ormulti-core). Also, the processes, modules, and sub-modules described inthe various figures of and for embodiments above may be distributedacross multiple computers or systems or may be co-located in a singleprocessor or system. Exemplary structural embodiment alternativessuitable for implementing the modules, sections, systems, means, orprocesses described herein are provided below.

The modules, processors or systems described above can be implemented asa programmed general purpose computer, an electronic device programmedwith microcode, a hard-wired analog logic circuit, software stored on acomputer-readable medium or signal, an optical computing device, anetworked system of electronic and/or optical devices, a special purposecomputing device, an integrated circuit device, a semiconductor chip,and a software module or object stored on a computer-readable medium orsignal, for example.

Embodiments of the method and system (or their sub-components ormodules), may be implemented on a general-purpose computer, aspecial-purpose computer, a programmed microprocessor or microcontrollerand peripheral integrated circuit element, an ASIC or other integratedcircuit, a digital signal processor, a hardwired electronic or logiccircuit such as a discrete element circuit, a programmed logic circuitsuch as a programmable logic device (PLD), programmable logic array(PLA), field-programmable gate array (FPGA), programmable array logic(PAL) device, or the like. In general, any process capable ofimplementing the functions or steps described herein can be used toimplement embodiments of the method, system, or a computer programproduct (software program stored on a non-transitory computer readablemedium).

Furthermore, embodiments of the disclosed method, system, and computerprogram product may be readily implemented, fully or partially, insoftware using, for example, object or object-oriented softwaredevelopment environments that provide portable source code that can beused on a variety of computer platforms. Alternatively, embodiments ofthe disclosed method, system, and computer program product can beimplemented partially or fully in hardware using, for example, standardlogic circuits or a very-large-scale integration (VLSI) design. Otherhardware or software can be used to implement embodiments depending onthe speed and/or efficiency requirements of the systems, the particularfunction, and/or particular software or hardware system, microprocessor,or microcomputer being utilized. Embodiments of the method, system, andcomputer program product can be implemented in hardware and/or softwareusing any known or later developed systems or structures, devices and/orsoftware by those of ordinary skill in the applicable art from thefunction description provided herein and with a general basic knowledgeof control systems and/or computer programming arts.

Moreover, embodiments of the disclosed method, system, and computerprogram product can be implemented in software executed on a programmedgeneral purpose computer, a special purpose computer, a microprocessor,or the like.

It is, thus, apparent that there is provided, in accordance with thepresent disclosure, peritoneal dialysis devices, methods and systems.Many alternatives, modifications, and variations are enabled by thepresent disclosure. Features of the disclosed embodiments can becombined, rearranged, omitted, etc., within the scope of the inventionto produce additional embodiments. Furthermore, certain features maysometimes be used to advantage without a corresponding use of otherfeatures. Accordingly, Applicants intend to embrace all suchalternatives, modifications, equivalents, and variations that are withinthe spirit and scope of the present invention.

What is claimed is:
 1. A method of providing dialysate for continuousambulatory peritoneal dialysis (CAPD), comprising: providing a deviceconfigured for preparing a first batch of dialysate for at least onedialysis treatment session, the device having a mixed batch containerinto which fluids are pumped to prepare said first batch of dialysatefor use in a cycler-assisted peritoneal dialysis treatment; preparingsaid first batch of dialysate using said device; performingcycler-assisted peritoneal dialysis treatment using said device, theperforming including conveying dialysate from said first batch in saidmixed batch container to a patient's peritoneum with a pumping portionof said device, extracting said dialysate from said first batch from thepatient's peritoneum, and measuring net fluid gain or loss between thefluid conveyed to the peritoneum and the fluid extracted from theperitoneum during said extracting; and preparing a second batch ofdialysate for CAPD using said device, the preparing the second batchincluding connecting a CAPD container to a predefined connector, andfilling said CAPD container by conveying fluid from said mixed batchcontainer to said CAPD container.
 2. The method of claim 1, wherein saidpreparing the second batch is performed responsively to a controllersignal indicating an end of a treatment cycle of which said performingthe cycler-assisted peritoneal dialysis treatment is a part.
 3. Themethod of claim 2, further comprising: performing a CAPD treatment usingsaid CAPD container.
 4. The method of claim 1, further comprising:performing a CAPD treatment using said CAPD container.
 5. A system forpreparing dialysate for continuous ambulatory peritoneal dialysis(CAPD), the system comprising: a fluid preparation and treatment deviceincluding concentrate dilution components connected to a source ofpurified water and medicament concentrate, the treatment device havingat least one mixing container connected via a pump and valves to saidsources, the valves and said pump being controlled by a controller tomix and dilute the concentrate to form a medicament; an auxiliary portfor attaching a CAPD container for receiving medicament therethrough;and a controller programmed to control the fluid preparation andtreatment device to implement one or more cycler-assisted peritonealdialysis treatment cycles using medicament from said mixing container,the controller controlling the fluid preparation and treatment devicepump and valves to prepare one or more batches of dialysate and to filland drain a peritoneum one or more times, wherein the controller isfurther configured to control the preparation of additional dialysate atthe end of the one or more cycler-assisted peritoneal dialysis treatmentcycles to fill the peritoneum and dispense additional dialysate throughsaid auxiliary port for use in CAPD.
 6. The system of claim 5, whereinthe dialysate flow from a batch container is routed to the peritoneumused for the cycler-assisted peritoneal dialysis treatment cycles and isalso routed to the auxiliary port to dispense the additional dialysate.7. The system of claim 6, wherein the valves include one valveexclusively used for conveying fluid from said auxiliary port.
 8. Thesystem of claim 5, wherein the valves include one valve exclusively usedfor conveying fluid from said auxiliary port.
 9. The system of claim 8,wherein the mixing container has a capacity sufficient to both fill aperitoneum for a cycle of a cycler-assisted peritoneal dialysistreatment and also to fill a peritoneum for use in CAPD.
 10. The systemof claim 7, wherein the mixing container has a capacity sufficient toboth fill a peritoneum for a cycle of a cycler-assisted peritonealdialysis treatment and also to fill a peritoneum for use in CAPD. 11.The system of claim 6, wherein the mixing container has a capacitysufficient to both fill a peritoneum for a cycle of a cycler-assistedperitoneal dialysis treatment and also to fill a peritoneum for use inCAPD.
 12. The system of claim 5, wherein the mixing container has acapacity sufficient to both fill a peritoneum for a cycle of acycler-assisted peritoneal dialysis treatment and also to fill aperitoneum for use in CAPD.
 13. The system of claim 12, wherein thevalves are connected to a manifold having a pumping tube segment. 14.The system of claim 11, wherein the valves are connected to a manifoldhaving a pumping tube segment.
 15. The system of claim 10, wherein thevalves are connected to a manifold having a pumping tube segment. 16.The system of claim 5, wherein the valves are connected to a manifoldhaving a pumping tube segment.
 17. The system of claim 12, wherein thepump is used by said fluid preparation and treatment device for mixingmedicament, for performing cycler-assisted peritoneal dialysistreatment, and for dispensing fluid for CAPD.
 18. The system of claim 9,wherein the pump is used by said fluid preparation and treatment devicefor mixing medicament, for performing cycler-assisted peritonealdialysis treatment, and for dispensing fluid for CAPD.
 19. The system ofclaim 6, wherein the pump is used by said fluid preparation andtreatment device for mixing medicament, for performing cycler-assistedperitoneal dialysis treatment, and for dispensing fluid for CAPD. 20.The system of claim 5, wherein the pump is used by said fluidpreparation and treatment device for mixing medicament, for performingcycler-assisted peritoneal dialysis treatment, and for dispensing fluidfor CAPD.